PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230),…
Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or…
Read the official notice →- Date
- 2026-05-20
- Country
- United States
- Brand
- Philips Medical Systems Nederland
- Product
- Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the country of Canada.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-06-03
USPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222),…
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Canada,…Official notice →- 2026-05-27
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12…
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Domestic: Nationwide; International: Canada, Algeria, Argentina, Australia,…Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and…
Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Nationwide distribution. International distribution to Albania, Algeria,…Official notice → - 2026-04-22
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to…
Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - 2026-04-08
- US
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 → - US
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 →
Other drugs & medical recalls in the United States
- 2026-05-20
- US
Integra LifeSciences Corp. (NeuroSciences) recalls Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD…
Out-of-specification endotoxin result that did not meet the acceptance criteria.
FDA · DeviceIntegra LifeSciences Corp. (NeuroSciences)US Nationwide distribution in the states of Arizona (AZ), Arkansas (AR),…Official notice → - US
Edwards Lifesciences, LLC recalls Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
FDA · DeviceEdwards Lifesciences, LLCWorldwide - US Nationwide distribution including in the states of AR, AZ, CA,…Official notice → - US
Aniara Diagnostica LLC recalls ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
FDA · DeviceAniara Diagnostica LLCUS Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA,…Official notice → - US
Quidel Corporation recalls QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
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FDA · DeviceQuidel CorporationUS Nationwide distribution in the states of AL, CA, FL, ID, IL, LA, MA, MD,…Official notice → - US
Hologic, Inc recalls SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D,…
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
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Stryker Corporation recalls Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the…
Due to nonconforming products being inadvertently distributed.