FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: Extended Brilliance Workspace Imaging Workstation. An independent diagnostic viewing and processing workstation, for CT images.
- Recall number
- Z-0889-06
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Product
- Extended Brilliance Workspace Imaging Workstation. An independent diagnostic viewing and processing workstation, for CT images.
- Status
- Terminated
- Initiated
- 2004-08-02
- Posted
- 2006-05-19
- Terminated
- 2012-03-02
- Reason
- Due to a software deficiency that occurs in the combine mode, a patients image can be filmed over a different patients image.
- Root cause
- Other
- Action
- Revised, corrected software has been shipped to consignees beginning June, 2004.
- Quantity
- 397 devices.
- Distribution
- The systems were installed at medical facilities located nationwide and worldwide.
- Lot, serial or model codes
- All serial numbers. Software version 1.0 or 1.0.1
- 510(k) numbers
- ["K012009"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 1525965
- Firm city
- Cleveland
- Firm state
- OH
- 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