FDA Device

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

Hazard

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

What You Should Do

Remedy

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.

Products

syngo US Workplace Picture Archiving and Communication System, software version 2.0, Siemens Medical Solutions, Inc., Mountain View, CA 94043
Brand
Siemens Medical Solutions USA, Inc.
UPC
Material number: 10035829, serial numbers: 250576, 260044, 260049, 260016, 250533, 250548, 250544, 250545, 250591, 250595, 250617, 700464562, 700465913, 700465914, 250565, 250557, and 250556.

Units Affected

17 units