Zenition 70 Medical Device Recall: Unintended Radiation Exposure Risk
Philips is recalling Zenition 70 systems with Vascular Extension option and Wireless Foot Switch due to potential for unintended radiation exposure in healthcare facilities.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 recall involving medical devices with a potential for unintended radiation exposure—a risk-of-harm hazard. No reported illnesses or injuries are stated in the source text, and the hazard is characterized as "potential," placing it at the upper boundary of High per the rubric.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling Zenition 70 systems equipped with the Vascular Extension option and Wireless Foot Switch. The devices are used in healthcare facilities both inside and outside operating rooms in sterile and non-sterile environments for various medical procedures.
The recall is due to the potential for unintended radiation exposure. Approximately 12 Zenition 70 systems with this configuration were distributed nationwide in the United States.
Healthcare facilities and providers using affected Zenition 70 systems with the Vascular Extension option and Wireless Foot Switch should contact Philips Medical Systems Nederland B.V. for further guidance and instructions on addressing this issue.
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.
- Affected units
- 12
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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