Philips Medical Systems Nederland B.V. High Tech Campus 36 Eindhoven Netherlands 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. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Philips Medical Systems Nederland B.V. High Tech Campus 36 Eindhoven Netherlands
Lot Codes / Batch Numbers
Zenition 70
Products Sold
Zenition 70
Philips Medical Systems Nederland B.V. High Tech Campus 36 Eindhoven Netherlands is recalling Zenition 70. The device is to be used in health care facilities both inside and outside the operatin due to Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foo. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.
Recommended Action
Per FDA guidance
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).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026