FDA Medical Device Recalls (openFDA)
PHILIPS HOME HEALTHCARE SOLUTION: ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system
- Recall number
- Z-0727-2021
- Recalling firm
- PHILIPS HOME HEALTHCARE SOLUTION
- Product
- ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system
- Status
- Terminated
- Initiated
- 2020-12-08
- Posted
- 2021-01-28
- Terminated
- 2024-06-21
- Reason
- After the user selects the Lock-in command, the kV and mA values are not locked immediately and can adjust if the collimator shutter position is changed directly after the Lock-in command.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- not on file
- Quantity
- 91
- Distribution
- Nationwide
- Lot, serial or model codes
- Pending
- 510(k) numbers
- ["K173433"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 3016860078
- Firm city
- Cambridge
- Firm state
- MA
- Firm country
- not on file
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