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…
Read the official notice →- Date
- 2025-06-18
- Country
- United States
- Brand
- Philips Medical Systems Nederland
- Product
- Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8)…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Afghanistan,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- 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
- 2025-09-10
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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 →- 2025-08-06
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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.
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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.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution: US (nationwide) to states of: CA, CO, DC, DE, FL, IL,…Official notice → - 2025-05-21
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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 → - 2025-05-14
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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 → - 2025-04-30
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Philips Medical Systems Nederland B.V. recalls Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as…
Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.
Other drugs & medical recalls in the United States
- 2025-06-25
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Aurobindo Pharma USA Inc recalls Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC…
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- 2025-06-18
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MicroAire Surgical Instruments, LLC recalls Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic…
Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
FDA · DeviceMicroAire Surgical Instruments, LLCWorldwide distribution - US Nationwide and the countries of Denmark, United…Official notice → - US
BD SWITZERLAND SARL recalls BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500
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A software update corrected an issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy.
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A software issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy.
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