Recall Z-0712-06 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA Inc
ECAT Emerge PET Scanners (distributed by Siemens Medical Solutions USA, Inc.), ECAT ART PET Scanners (distributed by Siemens Medical Solutions USA, Inc.) and Sceptre PET Scanners (distributed by Hitachi Medical Systems of America)
| Date | Apr 4, 2006 (initiated Mar 28, 2006) |
| Status | Terminated |
| Reason | There is a potential for inaccurate, elevated SUVs (standardized uptake values). On follow-up scans, the elevated SUV could be misinterpreted, and inappropriately impact a patient's treatment plan. |
| Root cause | Other |
| Action | Written notification was sent out beginning 03/28/2006 to end users to advise them of the problem. The notification also included specific work instructions to aid the end user until the patch is available and the upgrade could be performed by a service representative. |
| Quantity | 57 devices |
| Distribution | KS, WA, CA, OH, FL, TX, Germany, Great Britain, Canada Switzerland, Turkey, Argentina, Austria, France, & Spain |
| FDA record | Open on fda.gov |