Manufacturer

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

202 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 202

Severity pendingFDA (Devices)·Z-2411-2026·2026-06-24
Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost El
Pending LLM rewrite. Source: FDA_DEVICE Z-2411-2026.
Product
Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for MultiDiagnost Eleva with Flat Detector; Model # 708036 for MultiDiagnost Eleva; Model # 708037 for MultiDiagnost Eleva with Flat Detector; Model # 70803
Category
Medical Device
Distribution
0 states
Severity pendingFDA (Devices)·Z-2412-2026·2026-06-24
Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model #
Pending LLM rewrite. Source: FDA_DEVICE Z-2412-2026.
Product
Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura Xper FD10F; Model # 722003 for Allura Xper FD10; Model # 722005 for Allura Xper FD10/10; Model # 722006 for Allura Xper FD20; Model # 722008 for Allura Xper FD20
Category
Medical Device
Distribution
0 states
Severity pendingFDA (Devices)·Z-2291-2026·2026-06-10
Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R
Pending LLM rewrite. Source: FDA_DEVICE Z-2291-2026.
Product
Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-2290-2026·2026-06-10
Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R
Pending LLM rewrite. Source: FDA_DEVICE Z-2290-2026.
Product
Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-2284-2026·2026-06-10
Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2
Pending LLM rewrite. Source: FDA_DEVICE Z-2284-2026.
Product
Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-2285-2026·2026-06-10
Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R
Pending LLM rewrite. Source: FDA_DEVICE Z-2285-2026.
Product
Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-2288-2026·2026-06-10
Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3
Pending LLM rewrite. Source: FDA_DEVICE Z-2288-2026.
Product
Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-2289-2026·2026-06-10
Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0, R2.2.1, R2.2.3
Pending LLM rewrite. Source: FDA_DEVICE Z-2289-2026.
Product
Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-2287-2026·2026-06-10
Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 an
Pending LLM rewrite. Source: FDA_DEVICE Z-2287-2026.
Product
Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-2286-2026·2026-06-10
Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 an
Pending LLM rewrite. Source: FDA_DEVICE Z-2286-2026.
Product
Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-2258-2026·2026-06-03
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M
Pending LLM rewrite. Source: FDA_DEVICE Z-2258-2026.
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
Severity pendingFDA (Devices)·Z-2259-2026·2026-06-03
Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), A
Pending LLM rewrite. Source: FDA_DEVICE Z-2259-2026.
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-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
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-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
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
Severity pendingFDA (Devices)·Z-1805-2026·2026-04-22
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Intervent
Pending LLM rewrite. Source: FDA_DEVICE Z-1805-2026.
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
Severity pendingFDA (Devices)·Z-1660-2026·2026-04-08
ALLURA Xper FD10F; System Code: 722002;
Pending LLM rewrite. Source: FDA_DEVICE Z-1660-2026.
Product
ALLURA Xper FD10F; System Code: 722002;
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-1677-2026·2026-04-08
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
Pending LLM rewrite. Source: FDA_DEVICE Z-1677-2026.
Product
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-1679-2026·2026-04-08
Azurion 5 M12; System Code: (1)722227, (2)722231;
Pending LLM rewrite. Source: FDA_DEVICE Z-1679-2026.
Product
Azurion 5 M12; System Code: (1)722227, (2)722231;
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-1665-2026·2026-04-08
ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;
Pending LLM rewrite. Source: FDA_DEVICE Z-1665-2026.
Product
ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-1661-2026·2026-04-08
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
Pending LLM rewrite. Source: FDA_DEVICE Z-1661-2026.
Product
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-1678-2026·2026-04-08
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
Pending LLM rewrite. Source: FDA_DEVICE Z-1678-2026.
Product
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
Category
Medical Device
Distribution
Distributed nationwide
Severity pendingFDA (Devices)·Z-1668-2026·2026-04-08
Allura Xper FD20/10; System Code: 722029;
Pending LLM rewrite. Source: FDA_DEVICE Z-1668-2026.
Product
Allura Xper FD20/10; System Code: 722029;
Category
Medical Device
Distribution
Distributed nationwide