Use cautionMedical device recall · FDA · Published July 20, 2023
Philips Zenition 70 Medical Device Recall: Unintended Radiation Risk
Philips recalls Zenition 7:0 medical imaging systems with Vascular Extension option and Wireless Foot Switch due to potential unintended radiation exposure in healthcare settings.
Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.
Take action
Contact the company
📍Recalling firmPhilips Medical Systems Nederland B.V.High Tech Campus 36 · Eindhoven, Netherlands
“Philips Zenition 70 Medical Device Recall: Unintended Radiation Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/57621-philips-zenition-70-medical-device-recall-unintended-radiation-risk. Based on FDA recall #Z-1583-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1583-2025%22&limit=1).
The FDA announced on July 20, 2023, that Philips Medical Systems Nederland B.V. is recalling Zenition 70 systems due to the potential for unintended radiation exposure. The recall affects 12 units distributed nationwide in the United States.
How to tell if you have it
Brand: Philips
Product: Zenition 70
Configuration: Vascular Extension option and Wireless Foot Switch
Quantity: 12 systems
The hazard
Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems equipped with a Vascular Extension option and a Wireless Foot Switch. The device is intended for use in health care facilities both inside and outside the operating room.
Context
GovInfoNow's records show Philips Medical Systems Nederland B.V. has had 58 other recalls on record since May 26, 2021. Recent recalls include two software-related issues affecting Azurion R2.2.10 Systems reported on July 16, 2026, and a firmware issue potentially leading to loss of geometry movements reported on June 29, 2026. Other recent recalls of similar products include Philips Brilliance CT 64 Medical Scanner Recall (August 7, 2026), Philips IQon Spectral CT Software 4.7.7.x Recall (August 7, 2026), and Philips Ingenuity CT Scanners (August 7, 2026).
How to tell if you have this one
Check if your Zenition 70 system has the Vascular Extension option and Wireless Foot Switch. The device is used in healthcare facilities for various medical procedures.
Brand
Philips
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Configuration
Verify if your Zenition 70 system has the Vascular Extension option and Wireless Foot Switch installed.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 21 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1583-2025 (July 20, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1583-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.