Drugs & medicalClass II

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M20. Fluoroscopic X-Ray System.

Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.

Read the official notice →
Date
2025-07-30
Country
United States
Brand
Philips Medical Systems Nederland
Product
Azurion 7 M20. Fluoroscopic X-Ray System.
Classification
Class II
Units
Worldwide distribution: US (nationwide) to states of: CA, CO, DC, DE, FL, IL,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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. 2025-09-10
  2. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model…

    Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series.

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide distribution in the states of AL, AZ, CA, DC, FL,…Official notice →
  3. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with…

    Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice →
  4. 2025-08-06
  5. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper…

    Potential for temporary loss of imaging (X-ray) functionality due to software issue.

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide and the countries of Algeria, Argentina, Australia,…Official notice →
  6. 2025-06-18
  7. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7)…

    A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the…

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Afghanistan,…Official notice →
  8. 2025-05-21
  9. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Intera 1.5T Master/Nova, Model Number: 781106;

    The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin…

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.US: Nationwide Distribution International: Algeria, Andorra, Argentina,…Official notice →
  10. 2025-05-14
  11. US
    Drugs & medicalClass II

    Philips Medical Systems Nederland B.V. recalls IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.

    An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.

    FDA · DevicePhilips Medical Systems Nederland B.V.Domestic: Nationwide Distribution International: Australia, Austria, Belgium,…Official notice →
All 59 Philips Medical Systems Nederland recalls →

Other drugs & medical recalls in the United States

  1. 2025-07-30
  2. US
    Drugs & medicalClass II

    Olympus Corporation of the Americas recalls Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and…

    Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).

    FDA · DeviceOlympus Corporation of the AmericasInternational distribution to the country of Japan.Official notice →
  3. US
    Drugs & medicalClass II

    Natus Neurology DBA Excel Tech., Ltd. (XLTEK) recalls Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph

    Natus received two complaints of left side labeling show impedance for right side.

    FDA · DeviceNatus Neurology DBA Excel Tech., Ltd. (XLTEK)US: CA, IN, MO, NC, PA, RI, TXOfficial notice →
  4. US
    Drugs & medicalClass II

    CooperSurgical, Inc. recalls Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.

    The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.

    FDA · DeviceCooperSurgical, Inc.US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT,…Official notice →
  5. US
    Drugs & medicalClass II

    GE Medical Systems, LLC recalls SIGNA Architect

    GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result,…

    FDA · DeviceGE Medical Systems, LLCWorldwide distribution - US Nationwide and the country of China.Official notice →
  6. US
    Drugs & medicalClass II

    DIGIMED CO., LTD recalls Portable X-ray system

    Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.

    FDA · DeviceDIGIMED CO., LTDUSOfficial notice →
  7. US
    Drugs & medicalClass II

    Cipla USA, Inc. recalls Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd.…

    Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.

    FDA · DrugCipla USA, Inc.Distributed Nationwide in the USAOfficial notice →
See all drugs & medical recalls →