Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.
This recall is currently active, issued April 21, 2025. It was issued by Philips Medical Systems Nederland B.V. High Tech Campus 36 Eindhoven Netherlands.
- Recall Initiated
- July 20, 2023
- Posted
- April 21, 2025
- Recall Number
- Z-1583-2025
- Quantity
- 12 systems
- Official Source
- View on FDA website ↗
Reason for Recall
Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.
Distribution
US Nationwide distribution
Lot / Code Info
Zenition 70
Root Cause
Software design
Action Taken
Philips will send a customer notification to the existing users of the affected systems to alert them of the issue and provide the following actions that should be taken to prevent risks to patients: Keep the Electronic Product Radiation Correction letter with the documentation of the system. Where possible, place the Wireless Foot Switch within a 3 meter range from the C-arm stand to minimize as much as possible the potential delay of 72 milliseconds. Circulate this Electronic Product Radiation Correction letter to all users of the system so that they are aware of the issue. Philips will contact customers to schedule a visit to arrange for a Field Service Engineer visit to update the Software free of charge. (Philips reference 2024-IGT-PUN-007).