FDAJuly 20, 2023device

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.

Official recall recorded by the U.S. Food & Drug Administration.

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 enforcement status: Ongoing

Brands named

philips medical systems nederland b vphilipsphilips medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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