[pending] Zenition 70. The device is to be used in health care facilities both inside and outside the operatin
Pending LLM rewrite. Source: FDA_DEVICE Z-1583-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.
The recalled product
- 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.
- Manufacturer
- Philips Medical Systems Nederland B.V.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Zenition 70
Distribution
Distributed nationwide across the United States.
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