PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
127 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-09-13FDA-DeviceClass IIAllura Xper series
A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
- 2023-09-06FDA-DeviceClass IIWireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems
Loss of availability of the wireless foot switch during procedures.
- 2023-08-09FDA-DeviceClass IIAzurion 7 M20. X-ray Image guided Therapy System.
The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.
- 2023-08-09FDA-DeviceClass IIAllura Xper FD10 and FD20. X-ray Imaging System.
The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.
- 2023-06-07FDA-DeviceClass IIPhilips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 722063, 722221; (2) Azurion 3M15: 722064, 722222; (3) Azurion SM12: 722227; (4) Azurion SM20: 722228; (5) Azurion 7B12/12: 722067, 722225; (6) Azurion 7820/15: 722068, 722226; (7) Azurion 7M12: 722078, 722223; (8) Azurion 7M20 : 722079, 722224
Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the procedure
- 2023-04-26FDA-DeviceClass II2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1
There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.
- 2023-04-26FDA-DeviceClass IISmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.
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