MultiDiagnost-Eleva
This recall is currently active, issued September 7, 2023. It was issued by Philips Medical Systems Nederland B.V. High Tech Campus 36 Eindhoven Netherlands.
- Recall Initiated
- July 19, 2023
- Posted
- September 7, 2023
- Recall Number
- Z-2404-2023
- Quantity
- 5432 systems in total
- Official Source
- View on FDA website ↗
Reason for Recall
A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
Distribution
US Nationwide Distribution
Lot / Code Info
MultiDiagnost-Eleva
Root Cause
Radiation Control for Health and Safety Act
Action Taken
Philips will send a customer notification to the existing users of the affected systems to alert them of the issue and provide actions that should be taken by the customer/user in order to prevent risks to patients. Philips will contact customers to schedule a visit to inspect the foot switch and provide an addendum to the Instructions for Use (IFU) of the system detailing the appropriate cleaning and maintenance instructions. (Philips reference 2023-IGT-BST-011).