FDA Medical Device Recalls (openFDA)
Cti Pet Systems Inc: Siemens Models: BIOGRAPH, BIOGRAPH LSO and CTI Models: REVEAL HD, REVEAL RT
- Recall number
- Z-0106-04
- Recalling firm
- Cti Pet Systems Inc
- Product
- Siemens Models: BIOGRAPH, BIOGRAPH LSO and CTI Models: REVEAL HD, REVEAL RT
- Status
- Terminated
- Initiated
- 2003-10-02
- Posted
- 2003-11-13
- Terminated
- 2006-02-07
- Reason
- CPS has found that in some instances, when the CT E-Stop is activated, a malfunction may occur where the PHS controller may not shut down and stop bed motion.
- Root cause
- Other
- Action
- Written notification was sent out beginning 10/02/2003 to distributors and end users to advise them of the problem.
- Quantity
- 73
- Distribution
- Nationwide International: Japan, Germany, Brazil, Spain, China, Russia, Austrailia, Hong Kong, Singapore, Poland France, Korea, Greece, UK and Austria
- Lot, serial or model codes
- All CPS manufactured PET/CT systems distributed between October 31, 2000 and June 24, 2003.
- 510(k) numbers
- ["K013504","K002715"]
- PMA numbers
- not on file
- Product code
- KPS
- Firm FEI
- 1034973
- Firm city
- Knoxville
- Firm state
- TN
- 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