Philips Medical Systems Nederland B.v.: System, X-ray, Angiographic
Recall Summary Philips is recalling certain MultiDiagnost Eleva X-ray imaging systems because the hand switch button may not fully release after use, potentially causing the imaging system to stop working or resulting in unintended radiation exposure and extra contrast injection. The recall affects five specific model numbers of this angiographic X-ray equipment distributed in the US and worldwide. This is classified as a Class II recall, which means the problem could cause serious injury but is unlikely to result in death.
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- 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
- 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/7a34103c-c681-4127-a0ed-0aa5d9f19482