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.
FDA Recall Z-1583-2025 · Posted 2025-04-21
Recalling FirmPhilips Medical Systems Nederland B.V.
Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2023-07-20
Product Quantity12 systems
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.
Firm Action
Philips will send a customer notification to the existing users of the affected systems to alert them of the issue and provide the following actions that should be taken to prevent risks to patients:
Keep the Electronic Product Radiation Correction letter with the documentation of the
system.
Where possible, place the Wireless Foot Switch within a 3 meter range from the C-arm stand
to minimize as much as possible the potential delay of 72 milliseconds.
Circulate this Electronic Product Radiation Correction letter to all users of the system so that
they are aware of the issue.
Philips will contact customers to schedule a visit to arrange for a Field Service Engineer visit to
update the Software free of charge. (Philips reference 2024-IGT-PUN-007).
Root Cause
Software design
Distribution Pattern
US Nationwide distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.