Recall Z-2411-2026
- Recall number
- Z-2411-2026
- Event number
- 99223
- Firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands
- Firm FEI
- 3002807880
- Product code
- IZI
- Status
- Open, Classified
- Initiated
- 2026-05-18
- Posted
- 2026-06-16
- Root cause
- Radiation Control for Health and Safety Act
- 510(k) numbers
- K023441, K050151, K946378, K032443, K071619, K945540, K904540, K943355, K072591, K954309, K972136, K911732, K033184, K133993, K162991, K974679, K993947, K933073, K133719, K973368, K002840, K945459, K052500, K100849, K923813, K151780, K993763, K781991, K850455, K905653
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.
Reason for Recall#
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