—#67280

Product

Leonardo Workstation Picture Archiving and Communication System, Model Number: 7129534, Software Version: VB30B, Siemens Medical Solutions, Inc., Malvern, PA 19355

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K040970
Affected lot / code info: Model Number: 7129534. Serial Numbers: 10483, 10651, 10628, 10488, 10605, 10676, 10658, 10421, 10685, 10724, 10584, 10619, 10626, 10629, 10635, 10694, 10706, 10438, 10600, 10668, 10655, 10436, 10606, 10702, 10433, 10558, 10636, 10642, 10692, 10698, 10412, 10440, 10539, 10613, 10674, 10621, 10634, 10583, 10684, 10476, 10414, 10664, 10671, 10712, 10472, 10567, and 10641. Software version VB30B.

Why it was recalled

Incorrect display: The orientation labels will be incorrectly displayed on the reconstructed InSpace 3-D image if the orientation was not originally HFS on the acquisition system.

Root cause (FDA determination)

Software design

Action the firm took

Siemens Medical Solutions issued a Customer Safety Advisory Notice dated 12/21/07 to its customers to inform them of the problem and instructions to avoid the problem until the firm's representative is available to upgrade the software.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2007-12-21
Posted by FDA: 2008-04-29
Terminated: 2008-09-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #67280. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.