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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

206 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluor recall (Z-2485-2023)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2023-08-30
Allura Xper FD10 and FD20. X-ray Imaging System. recall (Z-2283-2023)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2023-08-02
Azurion 7 M20. X-ray Image guided Therapy System. recall (Z-2284-2023)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2023-08-02
SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6 recall (Z-1416-2023)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2023-04-20
2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1 recall (Z-1417-2023)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2023-04-20
Azurion systems with software release R1.x recall (Z-0886-2022)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2022-05-03
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