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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 corresp
Recalled September 10, 2025 · FDA recall Z-2502-2025 · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V
Hazard
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 Class II
Units
1,861 units
Sold at
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Korea, Republic of, Kosovo, Latvia, Lithuania, Macedonia, Maldives, Malta, Mexico, Moldova, Netherlands, New Caledonia, New Zealand, Nicaragua, Norway, Panama, Paraguay, Peru, Philippines, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam.
Description
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.
Product
Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Azurion 7 B20, Model Number 722068. 5. Azurion 7 M12, Model Number 722078. 6. Azurion 7 M20, Model Number 722079. 7. Azurion 3 M12, Model Number 722221. 8. Azurion 3 M15, Model Number 722222. 9. Azurion 7 M12, Model Number 722223. 10. Azurion 7 M20, Model Number 722224. 11. Azurion 7 B12, Model Number 722225. 12. Azurion 7 B20, Model Number 722226. 13. Azurion 5 M12, Model Number 722227. 14. Azurion 5 M20, Model Number 722228. 15. Azurion 7 M20, Model Number 722282.
Manufacturer(s)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Made in
Netherlands
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →