FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: Brillance CT System, 16 Power configuration using version 1.2 or 1.2.1 software.
- Recall number
- Z-1410-05
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Product
- Brillance CT System, 16 Power configuration using version 1.2 or 1.2.1 software.
- Status
- Terminated
- Initiated
- 2005-03-11
- Posted
- 2005-08-30
- Terminated
- 2012-03-02
- Reason
- When two product applications called Flip and Secondary Capture are used together, it is possible for image orientation labels to be incorrect.
- Root cause
- Other
- Action
- The firm sent recall/field correction letters dated 3/11/05.
- Quantity
- not on file
- Distribution
- The devices were distributed to consignees throughout the United States and to consigness located in Argentina, Austria, Bahama, Belarus, Belguim, Brazil, Canada, China, Chile, Columbia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador, England, Finland, France, Greece, Germany, Hungary, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Korea, Lebanon, Libya, Mexico, Morocco, Netherlands, New South Wales, New Zealand, Norway, Panama, Phillipines, Portugal, Poland, Romania, Russia, South Africa, Singapore, Slovenia, Spain, Sri Lanka, Switzerland, Sweden, Taiwan, Thailand, Turkey and Venezuela.
- Lot, serial or model codes
- All codes.
- 510(k) numbers
- ["K010817"]
- 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