Recall Z-0652-2007 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions, USA, Inc
Siemens syngo Dynamics 5.0 Workplace. Medical image report and archive system.
| Date | Mar 28, 2007 (initiated Jan 31, 2007) |
| Status | Terminated |
| Reason | The cardiac calculation feature may incorrectly calculate a derived V max value (reported out lower than it should be) and certain values imported into worksheets and reports may be incorrect due to a software defect. |
| Root cause | Other |
| Action | Distributors were issued a recall letter dated 1/29/07 and asked to notify their customers by issuing their subaccounts a similar letter. When available, new software will be provided. |
| Quantity | 71 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053133 | SYNGO DYNAMICS, VERSION 5.0 Siemens Medical Solutions USA, Inc., Dec 5, 2005 |