FDA recall Z-1583-2025

Philips Medical Systems Nederland B.V. · Class II · 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.

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

Key facts

Status
Ongoing
Initiation date
2023-07-20
Report date
2025-04-30
Voluntary/Mandated
FDA Mandated
Location
Eindhoven, N/A, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1583-2025