FDA Medical Device Recalls (openFDA)
Philips Medical Systems Nederland B.V.: 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 number
- Z-1583-2025
- Recalling firm
- Philips Medical Systems Nederland B.V.
- 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.
- Status
- Open, Classified
- Initiated
- 2023-07-20
- Posted
- 2025-04-21
- Terminated
- not on file
- Reason
- Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.
- Root cause
- Software design
- 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).
- Quantity
- 12 systems
- Distribution
- US Nationwide distribution
- Lot, serial or model codes
- Zenition 70
- 510(k) numbers
- ["K183040","K212813"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 3000976525
- Firm city
- Eindhoven
- Firm state
- not on file
- Firm country
- Netherlands
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28