—#67317

Product

syngo US Workplace Picture Archiving and Communication System, software version 2.0, Siemens Medical Solutions, Inc., Mountain View, CA 94043

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K060992
Affected lot / code info: Material number: 10035829, serial numbers: 250576, 260044, 260049, 260016, 250533, 250548, 250544, 250545, 250591, 250595, 250617, 700464562, 700465913, 700465914, 250565, 250557, and 250556.

Why it was recalled

Inaccurate results: A software bug may cause inaccurate wall motion abnormality scoring results to be displayed.

Root cause (FDA determination)

Software design

Action the firm took

Siemens Medical Solutions sent an Urgent Medical Device Notification letter, dated November 2007, to its consignees. The letter described action required by users, and that Siemens will contact the user with a new software version correcting this error. A field correction to update software is planned to be underway, designated to start on 12/21/2007, and the correction is expected to be completed within 45 days.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 1230 Shorebire Way P.O. Box 7393, Mountain View, California 94043

Distribution

Distribution pattern: Worldwide Distribution: South Korea, Malaysia, Lithuania and China, and 1 unit to New Jersey in the USA.

Timeline

Recall initiated: 2007-12-06
Posted by FDA: 2008-05-20
Terminated: 2010-12-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #67317. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.