—#73470

Product

Siemens syngo Dynamics Workplace, version 5.0, Siemens Medical Solutions, Ann Arbor, MI; 10090310. Intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.

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.

Why it was recalled

If the text is manually modified and additional phrases added as a result of worksheet interactions, some of the phrases may not populate the report.

Root cause (FDA determination)

Software design

Action the firm took

Consignees were notified of the problem via a Customer Safety Advisory Notice dated 7/23/08, which provided guidance on how to minimize the risk of the problem occurring, and told customers that a service patch will be installed when it becomes available.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2008-07-23
Posted by FDA: 2009-01-02
Terminated: 2010-10-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73470. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.