The Recall Desk

Manufacturer

Philips Medical Systems Nederland B.V.

209 recalls in our database name Philips Medical Systems Nederland B.V. as the manufacturing or recalling firm.

What the numbers show

Total
209
Critical
2
Severe
20
Most recent
2026-08-19

Of the 209 recalls from Philips Medical Systems Nederland B.V. we have scored against our rubric, 2 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 20 (10%) are Severe.

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 209

  • HighFDA (Devices)·Z-2932-2026·2026-08-19

    Philips Azurion Fluoroscopy System Recall for Software Image Quality Issues

    Philips is recalling 2,016 Azurion interventional fluoroscopic x-ray systems worldwide due to software defects that may degrade image quality or lose geometry movements, potentially delaying therapy or causing procedural complications.

    Product
    Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2928-2026·2026-08-19

    Philips Allura Xper FD Fluoroscopic X-Ray System Recalled for Firmware Issue

    Philips is recalling 4,252 Allura Xper FD interventional fluoroscopic x-ray systems worldwide due to a firmware issue that may cause loss of geometry movements.

    Product
    Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2931-2026·2026-08-19

    Philips Azurion Rystem X-Ray System Software Recall for Image Quality Issues

    Philips is recalling Azurion Rystem X-ray systems due to software defects that may degrade image quality or lose geometry movements, potentially delaying therapy or causing procedural complications.

    Product
    Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models are distributed only in China), with Software Version Number R2.2.10 and R2.1.10*
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2891-2026·2026-08-12

    Philips Allura X-Ray Systems Recalled Over Unauthorized Hard Disk Drives

    Philips is recalling 5,012 Allura interventional fluoroscopic X-ray systems nationwide due to potential loss of imaging functionality, motorized movement, or data caused by unauthorized hard disk drives.

    Product
    Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model Numbers: 722003, 722010, 722026. 2. Allura Xper FD10 OR Table; Model Number: 722033. 3. Allura Xper FD10/10; Model Numbers: 722005, 722011, 722027. 4. Allura
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2892-2026·2026-08-12

    Philips Azurion interventional fluoroscopic X-ray systems recalled for potential hardware failures

    Philips Azurion X-ray systems may lose imaging capability or motor functions due to unauthorized hard drives.

    Product
    Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12; Model Numbers: 722063, 722221. 2. Azurion 3 M15; Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12; Model Number: 722227. 4. Azurion 5 M20; Model Numbers: 7222
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2893-2026·2026-08-12

    Philips Fluoroscopy System Recall Over Hard Disk Drive Issue

    Philips is recalling 257 Allura/Centron interventional fluoroscopic X-ray systems due to potential loss of imaging, motorized movement, or data caused by unauthorized hard disk drives.

    Product
    Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2412-2026·2026-06-24

    Philips Allura Xper hand switch buttons may not fully release

    Philips Allura Xper and MultiDiagnost Eleva systems are being recalled because the hand switch button may not fully release, potentially causing loss of imaging or unintended radiation exposure.

    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
  • HighFDA (Devices)·Z-2411-2026·2026-06-24

    Philips MultiDiagnost Eleva hand switch buttons may not fully release

    Philips MultiDiagnost Eleva systems are being recalled because the hand switch button may not fully release, potentially causing loss of imaging or unintended radiation exposure.

    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
  • HighFDA (Devices)·Z-2288-2026·2026-06-10

    Philips Azurion 7B12 Roadmap Pro may produce unusable dark images

    Philips Azurion 7B12/12 systems with the Roadmap Pro software key are being recalled because a pedal tap may cause a dark, clinically unusable image on the next fluoroscopy run.

    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
  • HighFDA (Devices)·Z-2290-2026·2026-06-10

    Philips Azurion 7M12 Roadmap Pro may produce unusable dark images

    Philips Azurion 7M12 systems with the Roadmap Pro software key are being recalled because a pedal tap may cause a dark, clinically unusable image on the next fluoroscopy run.

    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
  • HighFDA (Devices)·Z-2284-2026·2026-06-10

    Philips Azurion 3M12 Roadmap Pro may produce unusable dark images

    Philips Azurion 3M12 systems with the Roadmap Pro software key are being recalled because a pedal tap may cause a dark, clinically unusable image on the next fluoroscopy run.

    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
  • HighFDA (Devices)·Z-2291-2026·2026-06-10

    Philips Azurion 7M20 Roadmap Pro may produce unusable dark images

    Philips Azurion 7M20 systems with the Roadmap Pro software key are being recalled because a pedal tap may cause a dark, clinically unusable image on the next fluoroscopy run.

    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
  • HighFDA (Devices)·Z-2286-2026·2026-06-10

    Philips Azurion 5M12 systems may show unusable dark fluoroscopy images

    Philips Azurion 5M12 systems with the Roadmap Pro software key are being recalled because a pedal tap may produce a dark image that is not clinically usable.

    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
  • HighFDA (Devices)·Z-2287-2026·2026-06-10

    Philips Azurion 5M20 Roadmap Pro may produce unusable dark images

    Philips Azurion 5M20 systems with the Roadmap Pro software key are being recalled because a pedal tap may cause a dark, clinically unusable image on the next fluoroscopy run.

    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
  • HighFDA (Devices)·Z-2289-2026·2026-06-10

    Philips Azurion 7B20/15 systems may show unusable dark fluoroscopy images

    Philips Azurion 7B20/15 systems with the Roadmap Pro software key are being recalled because a pedal tap may produce a dark image that is not clinically usable. 156 units affected.

    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
  • ModerateFDA (Devices)·Z-2285-2026·2026-06-10

    Philips Azurion 3M15 Medical Imaging Systems Recalled Due to Software Issue

    Philips Medical Systems is recalling 27 Philips Azurion 3M15 units because a software issue can cause unusable dark images during imaging procedures.

    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
  • HighFDA (Devices)·Z-2259-2026·2026-06-03

    Philips Allura system hard drives may degrade and lose imaging

    Philips Allura Xper interventional X-ray systems are being recalled because hard drives in the system PCs may lose performance as they age, potentially causing loss of imaging functionality.

    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-2258-2026·2026-06-03

    Philips Azurion system hard drives may degrade and lose imaging

    Philips Azurion interventional X-ray systems are being recalled because hard drives in the system PCs may lose performance as they age, potentially causing loss of imaging functionality.

    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-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
  • 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
  • HighFDA (Devices)·Z-1805-2026·2026-04-22

    Philips AneurysmFlow MAFA ratio does not give reliable prognostic information

    Philips is recalling AneurysmFlow because the Mean Aneurysm Flow Amplitude ratio does not reliably predict aneurysm occlusion after flow diverter stent treatment, yet is relied on clinically.

    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-1679-2026·2026-04-08

    Philips Azurion 5 M12 X-ray may not start from foot switch

    Philips is recalling the Azurion 5 M12 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.

    Product
    Azurion 5 M12; System Code: (1)722227, (2)722231;
    Category
    Medical Device
    Distribution
    Distributed nationwide