Recall Z-0106-04 ยท KPS System, Tomography, Computed, Emission
Cti Pet Systems Inc
Siemens Models: BIOGRAPH, BIOGRAPH LSO and CTI Models: REVEAL HD, REVEAL RT
| Date | Nov 13, 2003 (initiated Oct 2, 2003) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |