Manufacturer

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

192 recalls in our database name PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 192

HighFDA (Devices)·Z-2258-2026·2026-06-03
Philips Azurion and Allura Imaging Systems Recalled for Hard Drive Degradation
Philips is recalling certain Azurion and Allura medical imaging systems due to potential hard drive degradation after six years of service. The issue may cause loss of imaging functionality or motorized movement, though no injuries have been reported.
Product
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12 (722227), Azurion 5 M20 (722228), Azurion 7 B12 (722067, 722225), Azurion 7 B20 (722068, 722226), Azurion 7 M12 (722078, 722223), Azurion 7 M20 (
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2259-2026·2026-06-03
Philips Allura Imaging Systems Hard Drive Degradation Affects Functionality
Philips Allura fluoroscopic imaging systems may experience hard drive degradation after six years of service, potentially resulting in loss of imaging capability and motorized movement.
Product
Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allur
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2229-2026·2026-05-27
Integris-Allura X-ray systems with degraded deaeration hoses recalled
Philips is recalling Integris-Allura X-ray systems because deaeration hoses in X-ray tube cooling units may degrade, causing oil leakage that reduces cooling performance and triggers a system shutdown to low-dose mode.
Product
Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), Integris Allura 15 & 12 (monoplane) (722043), INTEGRIS Allura 15-12 (biplane) (722044), Integris-Allura 9 (722018), Integris-Allura 9 (Biplane) (722021), Integris CV
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2227-2026·2026-05-27
Azurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
The deaeration hose in Philips Azurion X-ray tube cooling units may degrade over time and leak oil, affecting cooling performance and automatically triggering low-dose fluoroscopy mode.
Product
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079, 722224).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2225-2026·2026-05-27
Philips Azurion X-Ray Systems Table Movement Control Defect Recall
Philips Azurion X-ray imaging systems may experience impaired table movement due to mechanical wear in the Float Tabletop control. The control module defect could affect longitudinal and transverse table positioning during medical procedures.
Product
Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers. 1. Azurion 3 M12; Model Numbers: 722063, 722229. 2. Azurion 3 M15; Model Numbers: 722222, 722064, 722280, 722230. 3.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2228-2026·2026-05-27
Philips Allura X-ray Systems Deaeration Hose Degradation Recall
Deaeration hoses in Philips Allura X-ray tube cooling units may degrade and leak oil, reducing cooling performance. Affected units were manufactured between February 2016 and May 2020.
Product
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 72
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2170-2026·2026-05-20
Philips Azurion X-Ray System Cable Hose Carriers May Loosen or Break
Bolts and plastic parts of cable hose carriers on Philips Azurion X-ray systems may loosen or break during monitor movement or rotation, potentially causing the cable hose to become unsecured.
Product
Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1805-2026·2026-04-22
Philips AneurysmFlow medical device software recalled for unreliable metric
Philips AneurysmFlow software is recalled because the Mean Aneurysm Flow Amplitude (MAFA) ratio does not reliably indicate aneurysm treatment success, yet physicians are relying on it for clinical decisions.
Product
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1677-2026·2026-04-08
Azurion 7 M12 X-ray system may not initiate imaging or operate intermittently
The Azurion 7 M12 X-ray imaging system may fail to initiate imaging or may operate intermittently due to a wired foot switch malfunction. No patient injuries have been reported.
Product
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1664-2026·2026-04-08
Philips X-ray System Imaging Failure with Wired Foot Switch
Philips ALLURA Xper FD20 biplane X-ray systems may fail to initiate imaging or operate intermittently when using the wired foot switch. A total of 461 units were affected.
Product
ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1668-2026·2026-04-08
Philips Allura Xper X-ray System: Wired Foot Switch May Fail to Initiate Imaging
Philips is recalling Allura Xper medical imaging systems due to wired foot switch failures that may prevent X-ray imaging from initiating or cause intermittent operation. No injuries have been reported, but affected units should be checked immediately.
Product
Allura Xper FD20/10; System Code: 722029;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1669-2026·2026-04-08
Philips Allura Xper FD20/20 X-ray System Foot Switch Malfunction
Philips is recalling 111 Allura Xper FD20/20 X-ray imaging systems due to a wired foot switch defect that may prevent imaging from being initiated or cause intermittent operation.
Product
Allura Xper FD20/20; System Code: 722038;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1660-2026·2026-04-08
Philips ALLURA X-ray system foot switch may not initiate imaging
Philips has identified a foot-switch malfunction on ALLURA Xper FD10F X-ray systems that may prevent imaging from starting or cause intermittent operation. The defect affects 10 systems and risks delaying diagnostic procedures.
Product
ALLURA Xper FD10F; System Code: 722002;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1659-2026·2026-04-08
Philips Allura Xper FD10C X-ray System Foot Switch Malfunction
Philips is recalling Allura Xper FD10C X-ray imaging systems due to a wired foot switch malfunction that may prevent or intermittently interrupt imaging. The recall affects 15 units distributed across the U.S. and internationally.
Product
Allura Xper FD10C; System Code: 722001;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1662-2026·2026-04-08
X-ray imaging system may not initiate or may malfunction due to foot switch defect
The Philips ALLURA Xper FD10/10 X-ray system may fail to initiate or operate intermittently when using its wired foot switch. Approximately 112 affected units have been distributed in the United States and internationally.
Product
ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1674-2026·2026-04-08
Philips Azurion 3 M15 X-ray imaging system foot switch failure
Philips Azurion 3 M15 X-ray imaging systems are being recalled because the wired foot switch malfunction may prevent X-ray imaging from initiating or cause imaging to occur intermittently. Approximately 798 units have been distributed in the United States and internationally.
Product
Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1672-2026·2026-04-08
Philips Allura Xper OR Table May Fail to Initiate X-Ray Imaging
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently on the Allura Xper FD20/15 OR Table when using the wired foot switch. This malfunction could impact imaging-guided surgical procedures.
Product
Allura Xper FD20/15 OR Table; System Code: 722059;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1665-2026·2026-04-08
ALLURA Xper FD20 OR Table Wired Foot Switch May Prevent X-Ray Initiation
Philips is recalling the ALLURA Xper FD20 OR Table because the wired foot switch may fail to initiate X-ray imaging or cause imaging to occur intermittently, which could delay critical diagnostic imaging during surgery.
Product
ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1673-2026·2026-04-08
Azurion X-ray imaging system wired foot switch may fail to initiate imaging
Philips Azurion 3 M12 X-ray systems are recalled due to wired foot switch malfunction that may prevent or interrupt X-ray imaging initiation. A total of 298 units are affected.
Product
Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1679-2026·2026-04-08
X-ray Imaging System Foot Switch Malfunction May Prevent Operation
The Azurion 5 M12 X-ray imaging system may fail to initiate imaging or operate intermittently when using the wired foot switch. Philips is recalling 345 units distributed in the US and internationally.
Product
Azurion 5 M12; System Code: (1)722227, (2)722231;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1676-2026·2026-04-08
Philips Azurion 7 B20 X-ray System Foot Switch May Fail to Initiate
Philips recalled Azurion 7 B20 X-ray systems due to foot switch malfunction that may prevent imaging initiation. Affects 1,523 units worldwide.
Product
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1670-2026·2026-04-08
Philips Allura Xper FD20/20 operating room X-ray table foot switch imaging defect
Philips has recalled the Allura Xper FD20/20 operating room X-ray table due to wired foot switch defects that may prevent or intermittently delay X-ray imaging. Five affected units have been distributed internationally.
Product
Allura Xper FD20/20 OR Table; System Code: 722039;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1680-2026·2026-04-08
Philips Azurion 5 M20 X-ray system foot switch may fail to initiate imaging
Azurion 5 M20 X-ray systems may fail to start imaging due to wired foot switch malfunction. No injuries reported.
Product
Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1675-2026·2026-04-08
Philips Azurion 7 B12 X-ray system wired foot switch malfunction recall
Philips is recalling Azurion 7 B12 X-ray imaging systems due to a wired foot switch defect that may prevent or cause intermittent X-ray image initiation.
Product
Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1667-2026·2026-04-08
Philips ALLURA surgical X-ray table foot switch imaging failure
Philips has issued a Class II recall for its ALLURA Xper FD10 operating table due to a wired foot switch defect that may prevent X-ray imaging from initiating or cause intermittent operation.
Product
ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;
Category
Medical Device
Distribution
Distributed nationwide