Philips Medical Systems Nederland B.v.: Azurion System; System Code Description (model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12 (722227), Az...
Azurion System Recall Summary Philips is recalling multiple models of its Azurion medical imaging systems worldwide because the hard drives in the computers powering these systems may degrade after six years of use, potentially causing loss of imaging capability or other functional problems. Depending on the specific system, the hard drive failure could result in loss of motorized movement or data loss, though restarting the system may temporarily restore function in some cases. The recall affects healthcare facilities using Azurion 3, 5, and 7 series systems across the U.S. and numerous countries globally.
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product
- Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12 (722227), Azurion 5 M20 (722228), Azurion 7 B12 (722067, 722225), Azurion 7 B20 (722068, 722226), Azurion 7 M12 (722078, 722223), Azurion 7 M20 (722079, 722224).
- Reason
- 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 system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-04-30
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussal, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus,...
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/2015c5df-915b-45b6-bc96-4a5552f6ce56