FDA Medical devices recall ·
Zenition 70. The device is to be used in health care facilities both… recall
- Recall number
- Z-1583-2025
- Date
- (initiated July 20, 2023)
- Company / brand
- Philips Medical Systems Nederland B.V.
High Tech Campus 36, Eindhoven, N/A, Netherlands - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 12 systems
- Initiated by
- FDA Mandated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Zenition 70
Distribution
US Nationwide distribution
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1583-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.