FDAFDA · Food and drugs·Recall number Z-1583-2025
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.
Published April 30, 2025 · Recall initiated: July 20, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
FDA Mandated · Letter
Recall details
- Manufacturer
- Philips Medical Systems Nederland B.V.
- Distributor
- US Nationwide distribution
- Lot
- Zenition 70
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Netherlands
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