Z-1583-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 30, 2025
- Initiation Date
- July 20, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 12 systems
Product Description
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.
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 Pattern
US Nationwide distribution
Code Information
Zenition 70