Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(ous Only); Software Version Number - All Versions: R1.x, R2.x, R3.x
Recall Summary Philips is recalling certain Azurion 5 M20 imaging systems (models 722228, 722232, and 722281) with software versions R1.X, R2.X, and R3.X because the examination table may move unexpectedly when the Reset Geometry button is pressed, even if the table lock is engaged. This is classified as a Class II recall, which indicates a serious potential health risk. The recall affects medical facilities using these specific system models and software versions.
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands
- Product
- Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
- Reason
- Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
- Classification
- Class II
- Category
- consumer product recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-01-26
- Status
- Open, Classified
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/de919d2c-416b-4253-a93f-2938ebf9e7ae