CLASS II ONGOING Device recall · Reported 30 Apr 2025 · FDA Enforcement Report
Zenition The device is to be used recalled by Philips Medical Systems
Philips Medical Systems Nederl is recalling Zenition The device is to be used in health care facilities both inside and outside the, distributed nationwide in the US. The recall was initiated on 20 Jul 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1583-2025
- FDA event ID
- 96598
- Recalling firm
- Philips Medical Systems Nederl, Eindhoven, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Jul 2023
- FDA classified
- 21 Apr 2025
- Reported
- 30 Apr 2025
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 20 Jul 2023 | Recall initiated by company | |
| 21 Apr 2025 | Classified by FDA | +641 days |
| 30 Apr 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution
Questions about this recall
Why was it recalled?
Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.
Which lots are affected?
Zenition 70
Where was it sold?
US Nationwide distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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