syngo US Workplace Picture Archiving and Communication System, software version 2.0, Siemens Medical Solutions, Inc., Mountain View, CA 94043
FDA Recall Z-1138-2008 · Posted 2008-05-20
Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2007-12-06
Date Terminated2010-12-20
Product Quantity17 units
Reason for Recall
Inaccurate results: A software bug may cause inaccurate wall motion abnormality scoring results to be displayed.
Firm Action
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.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution: South Korea, Malaysia, Lithuania and China, and 1 unit to New Jersey in the USA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.