PHILIPS 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…
Read the official notice →- Date
- 2026-06-03
- Country
- United States
- Brand
- Philips Medical Systems Nederland
- Product
- Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-08-12
USPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
- 2026-06-24
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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for…
Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection
- 2026-06-10
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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with…
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without…
- 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 → - 2026-05-20
- US
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…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the country of Canada.Official notice →
Other drugs & medical recalls in the United States
- 2026-06-10
- US
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Eugia US LLC recalls Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor,…
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
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Medline Industries, LP recalls Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627P
Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, Sterile. Cardinal Health has recalled these syringes because the outer carton and blister pack are labeled as a 1 mL Luer…
FDA · DeviceMedline Industries, LPUS Nationwide distribution in the states of California.Official notice → - US
GE Medical Systems Information Technologies Inc recalls GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA;…
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF…
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Devicor Medical Products Inc recalls HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
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FDA · DeviceDevicor Medical Products IncWorldwide distribution - US Nationwide and the countries of Canada, Singapore.Official notice →