Philips Medical Systems Nederland B.v. Veenpluis: Interventional Fluoroscopic X-ray System
Recall Summary Philips is recalling certain ALLURA Xper FD10/10 interventional X-ray systems because the wired foot switch may fail to initiate X-ray imaging or may cause imaging to occur intermittently. The affected systems are identified by system codes 722005, 722011, and 722027. These systems have been distributed nationwide in the U.S. and internationally across numerous countries.
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis
- Product
- ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;
- 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/c5c4533d-cedc-4f04-8adb-01d39a09bd15