Fusion Workstation.; Indicated for the transmission and review of radiological images.
This recall has been terminated (originally issued October 28, 2011).
- Company
- Merge Healthcare, Inc.
- Recall Initiated
- October 28, 2011
- Terminated
- December 14, 2016
- Recall Number
- Z-0294-2017
- Quantity
- 13 sites potentially hae the affected version
- Firm Location
- Hartland, WI
- Official Source
- View on FDA website ↗
Reason for Recall
After a period of time running Fusion Workstation, the Hounsfield measurement tool will report incorrect values.
Distribution
Distribution was made to AZ, CA, ID, IL, IN, MI, MN, and NJ.
Lot / Code Info
Versions V3.0.2 P3, 3.02, 3.1, 3.2, 3.3, and 3.3.1.
Root Cause
Software design
Action Taken
The recalling firm initiated phone calls to affected sites beginning 1/30/2016.
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