Siemens Models: BIOGRAPH, BIOGRAPH LSO and CTI Models: REVEAL HD, REVEAL RT
FDA device recall Z-0106-04 · posted 2003-11-13 · Terminated
Recall details
- Recalling firm
- Cti Pet Systems Inc
- Reason for recall
- 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.
- Action taken
- Written notification was sent out beginning 10/02/2003 to distributors and end users to advise them of the problem.
- Root cause
- Other
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 73
- Distribution
- Nationwide International: Japan, Germany, Brazil, Spain, China, Russia, Austrailia, Hong Kong, Singapore, Poland France, Korea, Greece, UK and Austria
- Date initiated
- 2003-10-02
- Date posted
- 2003-11-13
- Date terminated
- 2006-02-07
- Location
- Knoxville, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO: ECAT LSO PET/CT SCANNER (K013504) | Cti Pet Systems, Inc. | 2001-10-31 |
| ECAT PET SCANNER (K002715) | Cti Pet Systems, Inc. | 2000-10-31 |