Device product
Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for MultiDiagnost Eleva with Flat Detector; Model # 708036 for MultiDiagnost Eleva; Model # 708037 for MultiDiagnost Eleva with Flat Detector; Model # 708038 for MultiDiagnost Eleva with Flat Detector.
Z-2411-2026
Product summary
- Event
- Event 99223
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-2411-2026
Official wording
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
Code information: All codes
Distribution pattern: US and ROW.
Derived failure modes
-
Unknown
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