calendar
1,730 catalysts · 4,728 grant · 3,603 8k filing · 2,622 approval · 2,141 device 510k · 1,730 device recall · 1,490 device pma
next 91 dayslessmore
MonWedFri
1,730 catalysts · 4,728 grant · 3,603 8k filing · 2,622 approval · 2,141 device 510k · 1,730 device recall · 1,490 device pma
no tagged catalysts yet
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2 Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable — Reason: Their is the potential for weak staining which may result in false negative CD20 identification. — Status: Ongoing
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2J Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable — Reason: Their is the potential for weak staining which may result in false negative CD20 identification. — Status: Ongoing
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2CN Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable — Reason: Their is the potential for weak staining which may result in false negative CD20 identification. — Status: Ongoing
Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that monitors, measures, displays, records and stores various physiologic and blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices. The system is used for documenting and monitoring patients undergoing diagnostic and interventional catheter-based procedures. The procedures can be performed in the clinical areas of invasive cardiology, interventional radiology, and cardiac electrophysiology. — Reason: Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-3000 Patient Data Module (PDM) where certain units trigger an error message on the Merge Hemo Client ( Pressure Sensor Defective ) during non-invasive blood pressure (NIBP) measurements, specifically when the initial inflation pressure is set in the high-pressure range (>240 mmHg). The ARGUS PB-3000 is a vital signs monitoring instrument intended to be integrated into the Merge Hemo System. No other components of the Merge Hemo System are affected. — Status: Ongoing
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543. — Reason: Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results. — Status: Ongoing
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component. — Reason: Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries. — Status: Ongoing
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component. — Reason: Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries. — Status: Ongoing
Artis Pheno. Image-Intensified Flouroscopic X-Ray System. — Reason: Limited system movements after startup . — Status: Ongoing
NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 55, REF E NRT-06055-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients. — Reason: The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces. — Status: Ongoing
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component. — Reason: Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries. — Status: Ongoing
NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 55, REF E NRT-05055-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients. — Reason: The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces. — Status: Ongoing
NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 90, REF E NRT-06090-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients. — Reason: The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces. — Status: Ongoing
NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 90, REF E NRT-05090-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients. — Reason: The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces. — Status: Ongoing
Penner Pacific Bathing Spa, Model Numbers 360020-1P — Reason: The device does not bear a unique device identifier. — Status: Ongoing
UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322 — Reason: Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts. — Status: Ongoing
Penner Pacific Bathing Spa, Model Numbers 360020-1EP — Reason: The device does not bear a unique device identifier. — Status: Ongoing
Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT — Reason: The device does not bear a unique device identifier. — Status: Ongoing
Change Healthcare Radiology Solutions software version 14.2.2 — Reason: Due to software issue, radiology reports may not be fully displayed when viewing. — Status: Ongoing
Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306. — Reason: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. — Status: Ongoing
Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332. — Reason: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. — Status: Ongoing
Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model Number: 728244. — Reason: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. — Status: Ongoing
Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325. — Reason: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. — Status: Ongoing
UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478 — Reason: Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts. — Status: Ongoing
Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307. — Reason: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. — Status: Ongoing
Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number: 728246. 3. Brilliance CT 6 Slice, Model Number: 728256. — Reason: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. — Status: Ongoing
Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1 — Reason: The device does not bear a unique device identifier. — Status: Ongoing
Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model Number: 728231. 3. Ingenuity Flex, Model Number: 728317 — Reason: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. — Status: Ongoing
UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520 — Reason: Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts. — Status: Ongoing
Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370000-1WL, 360010-1L, 360010-1W, 360010-XWTL, 370000-XWL, 360010-1WTL, 360010-XWT, 360010-2, 370000-2W, 360010-2L, 370000-2WL, 360010-X, 370000-XW, 360010-2W, 362010-2, 360010, 37000-XWL, 362010-X, 362010-XL, 362010-1L, 360010-XL, 37000-1W, 360010-XW, 3700000-1W, 362010-2L, 36010-XWT, 370000-1L, 360010-2WT, 360000-1, 360010-XWSB, 360010-XLSB — Reason: The device does not bear a unique device identifier. — Status: Ongoing
Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X — Reason: The device does not bear a unique device identifier. — Status: Ongoing
Penner Pacific Bathing Spa, Model Numbers 860010-1L — Reason: The device does not bear a unique device identifier. — Status: Ongoing
Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL — Reason: The device does not bear a unique device identifier. — Status: Ongoing
UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858 — Reason: Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts. — Status: Ongoing
Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326, Model Number: 728323. 3. Ingenuity CT, Model Number: 728326. — Reason: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. — Status: Ongoing
Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X — Reason: The device does not bear a unique device identifier. — Status: Ongoing
Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324. — Reason: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. — Status: Ongoing
Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2 — Reason: The device does not bear a unique device identifier. — Status: Ongoing
Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311. — Reason: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. — Status: Ongoing
Heartstring III Proximal Seal System. Intravascular anastomosis occluder. — Reason: Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis. — Status: Ongoing
Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM LINER +0), REF: 322-42-03 (145-DEG PE 42MM HUM LINER +2.5) — Reason: Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling. — Status: Ongoing
Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder. — Reason: Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis. — Status: Ongoing
BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA00015, 6660E-PA00020, Q6660E-PA00011, 6660E-PA00021, 6660E-PA00016, 6660E-PA00019, Q6660E-PA00018, 6660E-PA00010, Q6660E-PA00010, Q6660E-PA00021, Q6660E-PA00012, 6660E-PA00030, 6660E-PA00041, 6660E-PA00035, 6660E-PA00032, 6660E-PA00031. Software Versions: 1.04.00.01, 01.05.00.01, 01.06.00.01, and 01.06.01.01 The patient monitor is intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters. — Reason: Potential for activation of an abnormal alarm pause. — Status: Ongoing
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Code: SXPP2B400-11. — Reason: Potential for barb non-engagement. — Status: Ongoing
Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEG PE 42MM HUM LINER +2.5/ — Reason: Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling. — Status: Ongoing
Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder. — Reason: Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis. — Status: Ongoing
ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000 — Reason: Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. — Status: Ongoing
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R. — Reason: Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard." — Status: Ongoing
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m — Reason: Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch. — Status: Ongoing
Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000 — Reason: Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. — Status: Ongoing
EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH202 — Reason: Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch. — Status: Ongoing