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Week of Sep 1, 2025

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Sep 3, 2025device pma343d agoEBR Systems, Inc. — WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System (PMA supplement)EBR Systems, Inc.

Supplement type: 30-Day Notice. Product code: SEG. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Sep 3, 2025device pma343d agoBolton Medical, Inc. — RelayPlus (PMA supplement)

Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Sep 3, 2025device pma343d agoBolton Medical, Inc. — TREO® Abdominal Stent-Graft System (PMA supplement)

Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Sep 3, 2025device recall343d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949; — Reason: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available. — Status: Ongoing

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Sep 3, 2025device recall343d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949; — Reason: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available. — Status: Ongoing

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Sep 3, 2025device recall343d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949; — Reason: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available. — Status: Ongoing

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Sep 3, 2025device recall343d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949; — Reason: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available. — Status: Ongoing

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Sep 3, 2025device recall343d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949; — Reason: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available. — Status: Ongoing

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Sep 3, 2025device recall343d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; — Reason: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted. — Status: Ongoing

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Sep 3, 2025device recall343d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; — Reason: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted. — Status: Ongoing

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Sep 3, 2025device recall343d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; — Reason: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted. — Status: Ongoing

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Sep 3, 2025device recall343d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; — Reason: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted. — Status: Ongoing

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Sep 3, 2025device recall343d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; — Reason: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted. — Status: Ongoing

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Sep 3, 2025device recall343d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949; — Reason: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available. — Status: Ongoing

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Sep 3, 2025device recall343d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; — Reason: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted. — Status: Ongoing

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Sep 3, 2025device recall343d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949; — Reason: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available. — Status: Ongoing

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Sep 3, 2025device recall343d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; — Reason: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted. — Status: Ongoing

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Sep 3, 2025device recall343d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; — Reason: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted. — Status: Ongoing

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Sep 3, 2025device recall343d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949; — Reason: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available. — Status: Ongoing

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Sep 3, 2025device recall343d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; — Reason: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted. — Status: Ongoing

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Sep 3, 2025device recall343d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; — Reason: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted. — Status: Ongoing

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Sep 3, 2025device recall343d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949; — Reason: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available. — Status: Ongoing

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Sep 3, 2025device recall343d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; — Reason: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted. — Status: Ongoing

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Sep 3, 2025device recall343d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; — Reason: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted. — Status: Ongoing

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Sep 3, 2025device recall343d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; — Reason: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted. — Status: Ongoing

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Sep 3, 2025device recall343d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949; — Reason: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available. — Status: Ongoing

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Sep 3, 2025device recall343d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; — Reason: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted. — Status: Ongoing

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Sep 3, 2025device recall343d agoFresenius Kabi USA, LLC device recall (Cls II)Fresenius Kabi USA LLC

Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. — Reason: Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation. — Status: Ongoing

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Sep 3, 2025device recall343d agoInpeco S.A. device recall (Cls II)

FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic — Reason: The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results. — Status: Ongoing

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Sep 3, 2025device recall343d agoInpeco S.A. device recall (Cls II)

FlexLab (FLX) System. Potassium Test System. in vitro diagnostic — Reason: The FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results. — Status: Ongoing

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Sep 3, 2025device recall343d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; — Reason: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted. — Status: Ongoing

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Sep 3, 2025device recall343d agoBeckman Coulter Inc. device recall (Cls II)

SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only. — Reason: Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which causes a delay in obtaining patient results. — Status: Ongoing

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Sep 3, 2025device recall343d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949; — Reason: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available. — Status: Ongoing

full page →fda device recalls ↗

Sep 3, 2025device recall343d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949; — Reason: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available. — Status: Ongoing

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Sep 3, 2025device recall343d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949; — Reason: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available. — Status: Ongoing

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Sep 4, 2025device 510k342d agoCarestream Health, Inc. — Image Suite (510k cleared)HEALTHSTREAM INC

Product code: LLZ. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗

Sep 4, 2025device 510k342d agoIschemaview, Inc. — Rapid Obstructive Hydrocephalus, Rapid OH (510k cleared)

Product code: QAS. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗

Sep 4, 2025device 510k342d agoOptina Diagnostics, Inc. — Optina-4C (MHRC-C1N) (510k cleared)Co-Diagnostics, Inc.

Product code: HKI. Advisory committee: Ophthalmic. Type: Traditional

full page →fda device 510k ↗

Sep 4, 2025device 510k342d agoCareverse Technology Pte. , Ltd. — Careverse CoronaryDoc (Careverse CoronaryDoc) (510k cleared)

Product code: QIH. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗

Sep 4, 2025device 510k342d agoBayer Medical Care, Inc. — Ball Joint Guide Array (66295) (510k cleared)

Product code: HAW. Advisory committee: Neurology. Type: Traditional

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Sep 4, 2025device 510k342d agoMicrobot Medical , Ltd. — LIBERTY Endovascular Robotic System (LIBERTYOS) (510k cleared)Microbot Medical Inc.

Product code: DXX. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗

Sep 4, 2025device 510k342d agoMicowey Medical Equipment (Guangxi) Co., Ltd. — Intense Pulsed Light Therapy Device (MMABM-1) (510k cleared)

Product code: ONF. Advisory committee: General, Plastic Surgery. Type: Traditional

full page →fda device 510k ↗

Sep 4, 2025device 510k342d agoThe Surgical Company International BV (As Tsc Life) — Fluido® AirGuard System (510k cleared)

Product code: LGZ. Advisory committee: General Hospital. Type: Traditional

full page →fda device 510k ↗

Sep 4, 2025device 510k342d agoMag & More GmbH — Apollo TMS Therapy System (510k cleared)

Product code: OBP. Advisory committee: Neurology. Type: Traditional

full page →fda device 510k ↗

Sep 4, 2025device 510k342d agoGuilin Woodpecker Medical Instrument Co., Ltd. — Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) (510k cleared)

Product code: EHD. Advisory committee: Dental. Type: Special

full page →fda device 510k ↗

Sep 4, 2025device 510k342d agoMedacta International S.A. — NextAR(TM) Shoulder Platform (510k cleared)Stemedica International S.A.

Product code: SBF. Advisory committee: Neurology. Type: Traditional

full page →fda device 510k ↗

Sep 4, 2025device 510k342d agoMedtronic Sofamor Danek USA, Inc. — Endoskeleton Interbody Systems (510k cleared)Medtronic USA Inc

Product code: MAX. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗

Sep 4, 2025device 510k342d agoMvision AI OY — Dose+ (1.0) (510k cleared)

Product code: MUJ. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗

Sep 4, 2025device 510k342d agoOniris — Oniris; Oniris Plus (510k cleared)

Product code: LRK. Advisory committee: Dental. Type: Traditional

full page →fda device 510k ↗

Sep 4, 2025device 510k342d agoABBOTT MEDICAL — EnSite X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01) (510k cleared)

Product code: DQK. Advisory committee: Cardiovascular. Type: Special

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