FDA-Device2025-04-30Class II
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.
Philips Medical Systems Nederland B.V.
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.
Sold states
US Nationwide distribution
Affected count
12 systems
Manufactured in
High Tech Campus 36, N/A, Eindhoven, N/A, Netherlands
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1583-2025Don't want to check this manually?
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