Philips Medical Systems Nederland B.v. Veenpluis: Interventional Fluoroscopic X-ray System
Recall Summary Philips is recalling certain Azurion 7 B20 X-ray systems because the wired foot switch may fail to start imaging or cause imaging to work only intermittently. The recall affects three specific system codes and applies to units distributed nationwide in the U.S. and internationally across numerous countries. This is a Class II recall, meaning the problem could cause serious health consequences but is not immediately life-threatening.
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis
- Product
- Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
- Reason
- Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-03
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/99a72f91-0cdb-48a4-8006-e414085afb63