Z-2411-2026 Class II Ongoing
FDA device recall Z-2411-2026 was initiated by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. on May 18, 2026 and is designated Class II. 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 contra… The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- June 24, 2026
- Initiation Date
- May 18, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
Product Description
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
Distribution Pattern
US and ROW.
Code Information
All codes