Zenition 70. The device is to be used in health care recall
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…
Why was Zenition 70. The device is to be used in health care 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 I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Zenition 70
- 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…
- Recalling firm
- Philips Medical Systems Nederland B.V.
- Quantity
- 12 systems
- Distribution
- US Nationwide distribution
- Recall date
- April 30, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)