FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: The Brilliance CT Big Bore is a whole body computed tomography X-Ray system. The malfunctioning software application is the Tumor Localization (Tumor LOC) application.
- Recall number
- Z-0121-2008
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Product
- The Brilliance CT Big Bore is a whole body computed tomography X-Ray system. The malfunctioning software application is the Tumor Localization (Tumor LOC) application.
- Status
- Terminated
- Initiated
- 2007-09-27
- Posted
- 2007-11-07
- Terminated
- 2012-03-02
- Reason
- The maximum intensity projection (MIP) images produced from respiratory gated images by the Tumor Localization (Tumor LOC) software application on Brilliance Big Bore CT scanners will be labeled incorrectly for certain patient orientations and view conventions when saved for later viewing.
- Root cause
- Software design
- Action
- Notification letters were sent to the installed customer base informing them of the hazard on 10/1/2007. A mandatory corrective software release due out mid October 2007, will be available at no cost to the customer. The software will be installed by Philips Field Service Engineers.
- Quantity
- 206 systems
- Distribution
- Worldwide, including USA, Canada, France, Finland, Korea, Australia, Italy, Switzerland, China, Austria, Thailand, Malaysia, Denmark, Norway, Jordan, Netherlands, England, South Africa, Spain, Germany, Bahrain, Belgium, New Zealand, Puerto Rico, South Korea, Saudi Arabia, Czech Republic, Sweden, Israel, and Lithuania
- Lot, serial or model codes
- All Brilliance CT Big Bore Scanners with Tumor Localization software versions v2.2.1, v2.2.2, & v2.2.5. This software version is included on Brilliance CT Big Bore Scanners, Model Number 728243, and Serial Numbers 7001 - 7215.
- 510(k) numbers
- ["K033357"]
- PMA numbers
- not on file
- Product code
- JAK
- 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