Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
This recall has been terminated (originally issued March 13, 2017).
- Company
- Merge Healthcare, Inc.
- Recall Initiated
- April 4, 2016
- Posted
- March 13, 2017
- Terminated
- June 22, 2020
- Recall Number
- Z-1681-2017
- Quantity
- 1,627 sites potentially have the affected software
- Firm Location
- Hartland, WI
- Official Source
- View on FDA website ↗
Reason for Recall
The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions.
Distribution
Distribution was made to medical facilities nationwide. Government distribution was made. Foreign distribution was made to Canada, as well as other countries. There was no military distribution.
Lot / Code Info
All versions of Eye Care PACS, Eye Station, and ESIU.
Root Cause
Software Design Change
Action Taken
The recalling firm issued a letter dated 3/28/2016 via e-mail the week of 4/4/2016. If no email address was available, the letters were issued via certified mail.
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