Philips Medical Systems Nederland B.v.: Interventional Fluoroscopic X-ray System
Philips is recalling multiple models of its Allura Xper interventional fluoroscopic X-ray systems used in medical facilities because the hand switch button may not fully release, which could result in loss of imaging during procedures or unintended radiation exposure and contrast injection. The recall affects various Allura Xper models distributed in the US and internationally. This is classified as a Class II recall, meaning the devices could cause serious health consequences but are unlikely to cause death.
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product
- Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura Xper FD10F; Model # 722003 for Allura Xper FD10; Model # 722005 for Allura Xper FD10/10; Model # 722006 for Allura Xper FD20; Model # 722008 for Allura Xper FD20 Biplane; Model # 722010 for Allura Xper FD10; Model # 722011 for Allura Xper FD10/10; Model # 722012 for Allura Xper FD20; Model # 722013 for Allura Xper FD20 Biplane; Model # 722015 for Allura Xper FD20 OR Table; Model # 722019 for Allura Xper FD10/10 OR Table; Model # 722020 for Allura Xper FD20 Biplane OR Table;...
- Reason
- Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-18
- Status
- Open, Classified
- Distribution
- US and ROW.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/4611a55c-48d8-4807-a421-da4ca964e663