Calendar

Week of Dec 8, 2025

Dec 8, 2025device pma251d agoMedtronic Minimed, Inc. — Simplera Sync Sensor (PMA supplement)Medtronic USA Inc

Supplement type: 30-Day Notice. Product code: SFI. Advisory committee: CH. Decision: OK30

Dec 8, 2025device recall251d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5. Azurion 7 B12. Model Number: 722235. 6. Azurion 7 B20. Model Number: 722236. 7. Azurion 7 M12. Model Number: 722233. 8. Azurion 7 M20. Model Number: 722234. — Reason: Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error. — Status: Ongoing

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Dec 8, 2025device recall251d agoIMRIS Imaging Inc device recall (Cls II)

Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600 Software Version: Not Applicable Product Description: The HFD100 Head Fixation Device provides rigid skeletal fixation within the optimal imaging envelope while introducing minimal artifacts in the acquired images. There are two different assemblies for the HFD100. The standard HFD100 is equipped with a table adapter for use with either the operating room table or the angiography table. For sites with a Hill-Rom TruSystem 7500 Hybrid Neuro MR Operating Table (ORT400), the HFD100 has a split block clamp assembly (Trumpf Mount Clamp Assembly) which connects directly to the table back section. The HFD100 system is also comprised of the linkage components to mount the skull clamp to the table adapter, and the 3-pin skull clamp. The linkage system is used to position the skull clamp in the necessary position, without colliding with the magnet bore. Component: Not a component. — Reason: Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of patient injury. — Status: Ongoing

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Dec 8, 2025device recall251d agoBeckman Coulter Ireland, Inc. device recall (Cls II)

The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterol esterase, cholesterol oxidase, peroxidase and 4- aminoantipyrine to generate a colorless end product. In phase two a second detergent in reagent 2 releases cholesterol from the LDL lipoproteins. This cholesterol reacts with cholesterol esterase, cholesterol oxidase and a chromogen system to yield a blue color complex which can be measured bichromatically at 540/660nm. The resulting increase in absorbance is directly proportional to the LDL-C concentration in the sample. — Reason: Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU). LDL Cholesterol reagent showed clinically significant interference due to triglyceride concentration up to 1500 mg/dL may cause a maximum positive bias of up to 28.8% in low LDL Cholesterol samples (concentration 80 mg/dL) and up to 11.02% in high LDL Cholesterol samples (concentration 160mg/dL). — Status: Ongoing

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Dec 8, 2025device recall251d agoSecuritas Healthcare LLC device recall (Cls II)

Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3 — Reason: Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots to (1) not transmit a low battery alert to the Arial Wireless Emergency Call System prior to battery failure, or (2) not transmit a low battery alert to the Arial Wireless Emergency Call system at least seven (7) days prior to the battery failing. — Status: Ongoing

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Dec 8, 2025device recall251d agoSecuritas Healthcare LLC device recall (Cls II)

Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3 — Reason: Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots to (1) not transmit a low battery alert to the Arial Wireless Emergency Call System prior to battery failure, or (2) not transmit a low battery alert to the Arial Wireless Emergency Call system at least seven (7) days prior to the battery failing. — Status: Ongoing

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Dec 9, 2025approval250d agoOXYCODONE HYDROCHLORIDE — FDA approvalANI PHARMACEUTICALS INC

Sponsor: ANI PHARMS. Form: SOLUTION. Route: ORAL

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Dec 9, 2025approval250d agoOXYCODONE HYDROCHLORIDE — FDA approvalANI PHARMACEUTICALS INC

Sponsor: ANI PHARMS. Form: SOLUTION. Route: ORAL

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Dec 9, 2025approval250d agoOXYCODONE HYDROCHLORIDE — FDA approvalANI PHARMACEUTICALS INC

Sponsor: ANI PHARMS. Form: SOLUTION. Route: ORAL

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Dec 9, 2025approval250d agoOXYCODONE HYDROCHLORIDE — FDA approvalANI PHARMACEUTICALS INC

Sponsor: ANI PHARMS. Form: SOLUTION. Route: ORAL

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Dec 9, 2025approval250d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE