iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.
This recall has been terminated (originally issued May 25, 2016).
- Company
- Merge Healthcare, Inc.
- Recall Initiated
- May 25, 2016
- Terminated
- August 28, 2019
- Recall Number
- Z-0611-2017
- Quantity
- 60 sites potentially have the affected versions
- Firm Location
- Hartland, WI
- Official Source
- View on FDA website ↗
Reason for Recall
Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed.
Distribution
Distribution was made to medical facilities nationwide. Foreign distribution was also made.
Lot / Code Info
Versions 3.0.1, 3.1, and 3.2
Root Cause
Software design
Action Taken
The recalling firm issued a notification letter dated 1/27/2016 via email or via certified mail if the firm did not have an email address for the customer. Nonresponders were issued a second letter dated 5/25/2016 on 5/26/2016.
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