Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as w
FDA device recall Z-1583-2025 · posted 2025-04-21 · Open, Classified
Recall details
- Recalling firm
- Philips Medical Systems Nederland B.V.
- 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.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 12 systems
- Distribution
- US Nationwide distribution
- Date initiated
- 2023-07-20
- Date posted
- 2025-04-21
- Location
- Eindhoven, Netherlands
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Zenition 70 (K212813) | Philips Medical Systems Nederland B.V. | 2021-10-01 |
| Zenition 70 (K183040) | Philips Medical Systems Nederland B.V. | 2018-12-06 |