ECAT Emerge PET Scanners (distributed by Siemens Medical Solutions USA, Inc.), ECAT ART PET Scanners (distributed by Sie
FDA device recall Z-0712-06 · posted 2006-04-04 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 57 devices
- Distribution
- KS, WA, CA, OH, FL, TX, Germany, Great Britain, Canada Switzerland, Turkey, Argentina, Austria, France, & Spain
- Date initiated
- 2006-03-28
- Date posted
- 2006-04-04
- Date terminated
- 2009-12-22
- 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 |
|---|---|---|
| ECAT PET SCANNER (K003241) | Cti Pet Systems, Inc. | 2000-12-13 |
| ECAT PRT (K940478) | Cti Pet Systems, Inc. | 1994-03-22 |