Somatom Sensation 16, Computed Tomography System, Diagnostic Imaging.
FDA device recall Z-0842-03 · posted 2003-05-16 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Perfusion CT is displaying a higher gray and color values than normal. A software problem.
- Action taken
- Update instructions on the new software were sent to the three customers on 8/2/2002. This update was followed up by a service representative to actually install the software.
- Root cause
- Other
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 1
- Distribution
- The product was distributed to three hospitals: Cleveland Clinic Foundation, Cleveland, OH; Brigham & Womens Hospital, Boston, MA; and Barnes Jewish Hosp. South Campus, Saint Louis, MO.
- Date initiated
- 2002-10-11
- Date posted
- 2003-05-16
- Date terminated
- 2006-10-03
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOMATOM P30 CT SYSTEMS (K013522) | Siemens Medical Systems, Inc. | 2001-11-07 |