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.

201–209 of 209

  • HighFDA (Devices)·Z-2284-2023·2023-08-09

    X-ray therapy system carriage bolts may loosen and suspension rail crack

    Philips Azurion 7 M20 X-ray imaging systems may have loose or broken carriage support bolts and cracks in the suspension rail. The Class II recall affects 648 units distributed worldwide.

    Product
    Azurion 7 M20. X-ray Image guided Therapy System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2283-2023·2023-08-09

    X-ray Imaging System Carriage Bolts May Loosen or Break

    Philips Allura Xper FD10 and FD20 X-ray systems may have loose or broken bolts supporting the FlexMove Carriage and cracks in the suspension rail. Affected units distributed worldwide; users should inspect equipment and contact manufacturer.

    Product
    Allura Xper FD10 and FD20. X-ray Imaging System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1647-2023·2023-06-07

    Philips Azurion X-ray Systems May Lose Imaging Capability When Storage Full

    Philips Azurion X-ray imaging systems may suddenly lose X-ray functionality when disk storage capacity is reached, potentially interrupting medical procedures.

    Product
    Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 722063, 722221; (2) Azurion 3M15: 722064, 722222; (3) Azurion SM12: 722227; (4) Azurion SM20: 722228; (5) Azurion 7B12/12: 722067, 722225; (6)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1417-2023·2023-04-26

    Philips 2D Perfusion Medical Imaging Software Recalled for Signal Processing Errors

    Philips is recalling 2D Perfusion diagnostic imaging software due to signal processing errors that can produce inaccurate presentations, potentially affecting clinical decisions.

    Product
    2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0886-2022·2022-05-11

    Azurion Medical Imaging System Software Defect Alters Dose Parameters

    A software defect in Philips Azurion imaging systems causes the Patient Type to change unexpectedly during study initiation, altering dose control parameters without operator notification.

    Product
    Azurion systems with software release R1.x
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0649-2022·2022-02-23

    Wireless Foot Switch Firmware Issue in Philips Veradius Unity Devices

    The wireless foot switch in Philips Veradius Unity medical systems can lose function due to a firmware issue. This could cause delays or interruption of medical procedures if alternative input methods are not used.

    Product
    Veradius Unity, Model #718132
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0648-2022·2022-02-23

    Philips Zenition 70 Wireless Foot Switch Firmware Failure Recall

    Philips is recalling Zenition 70 wireless foot switches due to a firmware issue that can cause the device to stop responding. This could interrupt imaging procedures if alternative controls are not used.

    Product
    Zenition 70, Model #718133
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0647-2022·2022-02-23

    Wireless Foot Switch May Stop Responding During Medical Procedures

    Philips is recalling Zenition 50 wireless foot switches (Model #718096) because a firmware issue can cause them to suddenly stop responding, potentially delaying medical procedures.

    Product
    Zenition 50, Model #718096
    Category
    Medical Device
    Distribution
    26 states