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Recall Observatory FDA recall evidence

Device 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.

Z-1583-2025

July 20, 2023

Class II

Product summary

Firm
Philips Medical Systems Nederland B.V.
Event
Event 96598
Status
Ongoing
Classification
Class II
Quantity
12 systems
Official record key
device-enforcement:Z-1583-2025

Official wording

Reason: Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.

Code information: Zenition 70

Distribution pattern: US Nationwide distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.