FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: Brilliance CT System, Big Bore Configuration, Model #728243. (version 2.2.1)
- Recall number
- Z-0636-2007
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Product
- Brilliance CT System, Big Bore Configuration, Model #728243. (version 2.2.1)
- Status
- Terminated
- Initiated
- 2006-10-02
- Posted
- 2007-03-17
- Terminated
- 2012-03-26
- Reason
- Two conditions have been identified with the Philips Medical System Brilliance Bore ,version 2.2.1 Tumor Localization, that may lead the user to misinterpret the displayed data.
- Root cause
- Other
- Action
- Customer advisory notification letters dated 10/4/06 and 10/25/06 were sent to consignees providing short term work around instructions. Software modifications installed by the recalling firm will follow as the long term correction.
- Quantity
- 17 units
- Distribution
- Class II Recall-Nationwide Distribution-USA including states of KY, MD, TX, RI, NJ, MA, LA, VA, PA, SC, CA, OH, and FL.
- Lot, serial or model codes
- Serial numbers 7009, 7056, 7060, 7066, 7069, 7072, 7079, 7088, 7111, 7112, 7113, 7114, 7117, 7118, 7119, 7121, 7125.
- 510(k) numbers
- ["K033357"]
- PMA numbers
- not on file
- Product code
- not on file
- 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