Siemens Medical Solutions, USA, Inc Siemens syngo Dynamics 5.0 Workplace. Medical image report and archive system. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Siemens syngo Dynamics 5.0 Workplace. Medical image report and archive system.
Brand
Siemens Medical Solutions, USA, Inc
Lot Codes / Batch Numbers
All units. Version 5.0
Products Sold
All units. Version 5.0
Siemens Medical Solutions, USA, Inc is recalling Siemens syngo Dynamics 5.0 Workplace. Medical image report and archive system. due to The cardiac calculation feature may incorrectly calculate a derived V max value (reported out lower than it should be) and certain values imported int. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026