—#73469

Product

Siemens KinetDx 4.2 Workplace, Siemens Medical Solutions, Ann Arbor, MI; 10090235. Indicated for use by the physician to aid in diagnosis, and by medical professionals whenever they would require or desire access to medical images and patient demographic information.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K040896
Affected lot / code info: All units.

Why it was recalled

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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 #73469. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.