Drugs & medicalClass II

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion system; Software Version Number: R3.1;

Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content and/or loss of data.…

Read the official notice →
Date
2026-01-28
Country
United States
Brand
Philips Medical Systems Nederland
Product
Philips Azurion system; Software Version Number: R3.1;
Classification
Class II
Units
International distribution in the countries of AE, AR, AT, AZ, BE, BG, BH, BR,…
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Philips Medical Systems Nederland recalls

  1. 2026-04-08
  2. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Vue Motion V12. Product Number: 1017979.

    Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Algeria, Andorra,…Official notice →
  3. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;

    Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Domestic: Nationwide Distribution; International: Afghanistan, Albania,…Official notice →
  4. 2026-02-18
  5. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.X,…

    Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Afghanistan,…Official notice →
  6. 2026-01-21
  7. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and…

    Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the…

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Afghanistan,…Official notice →
  8. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model…

    Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD…

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Albania, Algeria,…Official notice →
  9. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD10F; Model Number: 722002;

    Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately…

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice →
All 59 Philips Medical Systems Nederland recalls →

Other drugs & medical recalls in the United States

  1. 2026-01-28
  2. US
    Drugs & medicalClass II

    Mazor Robotics Ltd recalls Mazor X robotic guidance system REF: TPL0059

    Software errors that can result in incorrect surgical instrument positioning during spinal surgery.

    FDA · DeviceMazor Robotics LtdWorldwide distribution - US Nationwide and the countries of Australia,…Official notice →
  3. US
    Drugs & medicalClass II

    Baxter Healthcare Corporation recalls SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

    Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication…

    FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution.Official notice →
  4. US
    Drugs & medicalClass II

    ICU Medical, Inc. recalls ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)

    Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at…

    FDA · DeviceICU Medical, Inc.Worldwide distribution - US Nationwide and the country of Philippines.Official notice →
  5. US
    Drugs & medicalClass II

    GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni…

    There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most easily identified in transaxial slices on…

    FDA · DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGWorldwide distribution. US Nationwide, Argentina, Australia, Belgium, Brazil,…Official notice →
  6. US
    Drugs & medicalClass II

    ICU Medical, Inc. recalls Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000

    Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear;…

    FDA · DeviceICU Medical, Inc.Worldwide - US Nationwide distribution including in the states of FL, AZ, RI,…Official notice →
  7. US
    Drugs & medicalClass II

    RAYSEARCH LABORATORIES AB recalls Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025,…

    Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material…

    FDA · DeviceRAYSEARCH LABORATORIES ABRefer to the attached documents: Distribution list 167168 US - updated,…Official notice →
See all drugs & medical recalls →