—#50395

Product

Siemens syngo Dynamics 5.0 Workplace. Medical image report and archive system.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K053133
Affected lot / code info: All units. Version 5.0

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions, USA, Inc
Address: 400 Morgan Rd, Ann Arbor, Michigan 48108

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2007-01-31
Posted by FDA: 2007-03-28
Terminated: 2008-04-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #50395. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.