Medical DeviceApr 24, 2024
Philips Ingenia Ambition X, Magnetic Resonance System recall — FDA Z-1569-2024
Patient support table floor plate may be incorrectly installed.
Class IIFDA: OngoingPhilips North America LLC
April 2024 recalls — page 2
These records include useful source details for the selected month.
Medical DeviceApr 24, 2024
Philips MR 5300, Magnetic Resonance System recall — FDA Z-1587-2024
Patient support table floor plate may be incorrectly installed.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceApr 24, 2024
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm recall — FDA Z-1397-2024
Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can contain some microscopic debris on the inside of the biopsy needle. The material in the debris…
Class IFDA: OngoingElekta Instrument AB
Medical DeviceApr 24, 2024
Philips Achieva 3.0T for PET, Magnetic Resonance System recall — FDA Z-1554-2024
Patient support table floor plate may be incorrectly installed.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceApr 24, 2024
Philips SmartPath to dStream for 1.5T, Magnetic Resonance System recall — FDA Z-1589-2024
Patient support table floor plate may be incorrectly installed.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceApr 24, 2024
Smith & Nephew Medical RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients recall — FDA Z-1596-2024
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
Class IIFDA: OngoingSmith & Nephew Medical, Ltd.
Medical DeviceApr 24, 2024
Philips Evolution Upgrade 3.0T, Magnetic Resonance System recall — FDA Z-1558-2024
Patient support table floor plate may be incorrectly installed.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceApr 24, 2024
Philips Intera 1.0T Power/Pulsar, Magnetic Resonance System recall — FDA Z-1574-2024
Patient support table floor plate may be incorrectly installed.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceApr 24, 2024
Cook Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for recall — FDA Z-1532-2024
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Class IIFDA: OngoingCook Inc.
Medical DeviceApr 24, 2024
Philips Achieva 1.5T Initial, Magnetic Resonance System recall — FDA Z-1552-2024
Patient support table floor plate may be incorrectly installed.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceApr 24, 2024
Philips Intera 1.5T R11, Magnetic Resonance System recall — FDA Z-1583-2024
Patient support table floor plate may be incorrectly installed.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceApr 24, 2024
Philips Achieva 1.5T Conversion, Magnetic Resonance System recall — FDA Z-1551-2024
Patient support table floor plate may be incorrectly installed.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceApr 24, 2024
Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor recall — FDA Z-1598-2024
Coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the…
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
Medical DeviceApr 24, 2024
Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only recall — FDA Z-1538-2024
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Class IIFDA: OngoingMasimo Corporation
Medical DeviceApr 24, 2024
Philips Respironics Trilogy Evo O2, all software versions except 1.05.06.00 recall — FDA Z-1503-2024
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
Class IFDA: OngoingPhilips Respironics, Inc.
Medical DeviceApr 24, 2024
Philips Intera CV, Magnetic Resonance System recall — FDA Z-1586-2024
Patient support table floor plate may be incorrectly installed.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceApr 24, 2024
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) recall — FDA Z-1540-2024
Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect…
Class IIFDA: OngoingSmiths Medical ASD Inc.
Medical DeviceApr 24, 2024
Philips Achieva 3.0TX for PET, Magnetic Resonance System recall — FDA Z-1555-2024
Patient support table floor plate may be incorrectly installed.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceApr 24, 2024
Philips Intera Achieva 1.5T Pulsar, Magnetic Resonance System recall — FDA Z-1585-2024
Patient support table floor plate may be incorrectly installed.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceApr 24, 2024
Philips GYROSCAN T5, Magnetic Resonance System recall — FDA Z-1561-2024
Patient support table floor plate may be incorrectly installed.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceApr 24, 2024
Philips MR 7700, Magnetic Resonance System recall — FDA Z-1588-2024
Patient support table floor plate may be incorrectly installed.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceApr 24, 2024
Cook Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous recall — FDA Z-1526-2024
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Class IIFDA: OngoingCook Inc.
Medical DeviceApr 24, 2024
Cook Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid recall — FDA Z-1527-2024
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Class IIFDA: OngoingCook Inc.
Medical DeviceApr 24, 2024
Philips Enterprise 1.5T, Magnetic Resonance System recall — FDA Z-1557-2024
Patient support table floor plate may be incorrectly installed.
Class IIFDA: OngoingPhilips North America LLC
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.