Fusion Workstation.; Indicated for the transmission and review of radiological images.
FDA Recall Z-0294-2017 · Posted None
Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2011-10-28
Date Terminated2016-12-14
Product Quantity13 sites potentially hae the affected version
Reason for Recall
After a period of time running Fusion Workstation, the Hounsfield measurement tool will report incorrect values.
Firm Action
The recalling firm initiated phone calls to affected sites beginning 1/30/2016.
Root Cause
Software design
Distribution Pattern
Distribution was made to AZ, CA, ID, IL, IN, MI, MN, and NJ.
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.