syngo MultiModality WorkPlace (MM WP). Software product(Model Number 10140720). The product is intended for use in picture archiving and communications system.
FDA Recall Z-0324-2009 · Posted 2008-12-03
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2008-09-12
Date Terminated2009-09-23
Product Quantity130 units
Reason for Recall
Values derived from Dynamic CT data sets may be incorrect. The corresponding images are not affected.
Firm Action
The recalling firm has issued a software update to affected customers via Update Instructions CT034/08/S. This software update corrects the values from the volume perfusion post processing application. A firm representative will visit each consignee to install the software update beginning 9/12/08.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution.
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.