Recall Z-1138-2008 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc.
syngo US Workplace Picture Archiving and Communication System, software version 2.0, Siemens Medical Solutions, Inc., Mountain View, CA 94043
| Date | May 20, 2008 (initiated Dec 6, 2007) |
| Status | Terminated |
| Reason | Inaccurate results: A software bug may cause inaccurate wall motion abnormality scoring results to be displayed. |
| Root cause | Software design |
| Action | Siemens Medical Solutions sent an Urgent Medical Device Notification letter, dated November 2007, to its consignees. The letter described action required by users, and that Siemens will contact the user with a new software version correcting this error. A field correction to update software is planned to be underway, designated to start on 12/21/2007, and the correction is expected to be completed within 45 days. |
| Quantity | 17 units |
| Distribution | Worldwide Distribution: South Korea, Malaysia, Lithuania and China, and 1 unit to New Jersey in the USA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060992 | SYNGO US WORKPLACE Siemens Medical Solutions, Apr 28, 2006 |