Philips Zenition 70 Imaging System Potential Radiation Exposure Recall
Philips is recalling Zenition 70 imaging systems with Vascular Extension and Wireless Foot Switch due to potential unintended radiation exposure. Twelve systems were distributed nationwide.
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: This is an FDA Class II medical device recall for potential radiation exposure without reported illnesses, injuries, or hospitalization. Radiation hazards represent a high-risk category, and the product meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling Zenition 70 imaging systems equipped with the Vascular Extension option and Wireless Foot Switch. These are diagnostic imaging devices used in healthcare facilities both inside and outside operating rooms for various clinical procedures.
The recall was initiated due to the potential for unintended radiation exposure associated with the specified equipment combination. The source does not indicate that radiation incidents have occurred.
This recall affects 12 Zenition 70 systems with the Vascular Extension option and Wireless Foot Switch distributed across the United States. Healthcare facilities using these specific equipment configurations should contact Philips for guidance on appropriate corrective actions.
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.
- Hazard
- radiation-exposure
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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