Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 ...
Reason for Recall / Hazard
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
Product Description & Identification
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.
Affected Products
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Best |
| Event id | 99223 |
| Address 1 | Veenpluis 4-6 |
| Code info | All codes |
| Postal code | N/A |
| Report date | 20260624 |
| Product type | Devices |
| 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 |
| Voluntary mandated | FDA Mandated |
| Recall initiation date | 20260518 |
| Center classification date | 20260616 |
Overview
- Recalling FirmPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- StatusOngoing
- Risk LevelClass II
- DistributionUS and ROW.