Merge OrthoPACS software.
This recall has been terminated (originally issued May 24, 2017).
- Company
- Merge Healthcare, Inc.
- Recall Initiated
- May 24, 2017
- Terminated
- June 28, 2019
- Recall Number
- Z-2620-2017
- Quantity
- 98 sites potentially have the affected versions
- Firm Location
- Hartland, WI
- Official Source
- View on FDA website ↗
Reason for Recall
A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.
Distribution
Distribution was made nationwide to medical facilities. There was no foreign/government/military distribution.
Lot / Code Info
Versions 6.6, 6.6.1, and 6.6.2
Root Cause
Software design
Action Taken
The recalling firm issued a letter dated 5/19/2017 via email on 5/24/2017 or via certified mail if they did not have an email address for the customer.
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