PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: 66 recalls on record

Recalls filed with 1 agency: FDA (66).

First recall on record: February 23, 2022. Most recent: August 19, 2026.

Risk classification: Class I: 2 · Class II: 64

Most recent recalls

DateAgencyProduct
October 29, 2025FDAZenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray systemZ-0241-2026
October 8, 2025FDAAllura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s…Z-0002-2026
October 8, 2025FDAAllura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K1308…Z-0010-2026
October 8, 2025FDAAllura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K1308…Z-0009-2026
October 8, 2025FDAAllura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K1306…Z-0013-2026
October 1, 2025FDAAllura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers…Z-2625-2025
September 17, 2025FDAIntelliSpace Cardiovascular, Software 8.0.0.4.Z-2543-2025
May 21, 2025FDASmartPath to dStream for 1.5T, Model Number: 782146;Z-1782-2025
May 21, 2025FDAIntera 1.5T Master/Nova, Model Number: 781106;Z-1776-2025
May 14, 2025FDAIntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.Z-1740-2025
April 30, 2025FDAZenition 70. The device is to be used in health care facilities both inside and outside t…Z-1583-2025
March 19, 2025FDASpectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;Z-1324-2025
February 26, 2025FDAAzurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).Z-1154-2025
February 26, 2025FDAAllura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.Z-1145-2025
February 12, 2025FDAAzurion 3 M12 System Code: (1) 722063 (2) 722221Z-1087-2025
December 18, 2024FDAPhilips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD1…Z-0676-2025
November 20, 2024FDAPhilips Zenition 50, Model Number: 718096Z-0352-2025
November 20, 2024FDAPhilips Zenition 70, Model Number: 718133Z-0353-2025
September 25, 2024FDASystem Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 A…Z-3165-2024
September 25, 2024FDASystem Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost Eleva wit…Z-3168-2024
September 25, 2024FDASystem Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 722039 Allura…Z-3166-2024
September 25, 2024FDASystem Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Vi…Z-3167-2024
September 11, 2024FDAPhilips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluorosc…Z-2953-2024
August 28, 2024FDAPhilips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray Sy…Z-2716-2024
August 14, 2024FDAPhilips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R…Z-2534-2024

Questions about this company

How many recalls does PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. have?
Recalert has 66 U.S. recalls on record for PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., published between February 23, 2022 and August 19, 2026.
Which agencies have handled PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls?
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. appears as the recalling firm in recalls from: FDA (66).

Do you carry products from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.? Check your whole catalog free against 80,000+ recalls.

Paste up to 100 UPCs or SKUs and see which ones match a CPSC, FDA, NHTSA or FSIS recall. No account needed.

Check my catalog free

Want it checked every night instead? Starter watches 500 SKUs for $29/month. See plans

Related companies