Class II

Medical Device Recall: 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. · July 20, 2023

Reason for Recall

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

Distribution

US Nationwide distribution

States Affected

NATIONWIDE

Quantity Affected

12 systems

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1583-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Philips Medical Systems Nederland B.V. Medical Device Recall: 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. | SafeCheck