Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
Reported: April 5, 2017 Initiated: April 4, 2016 #Z-1681-2017
Product Description
Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
Reason for Recall
The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions.
Details
- Recalling Firm
- Merge Healthcare, Inc.
- Units Affected
- 1,627 sites potentially have the affected software
- 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.
- Location
- Hartland, WI
Frequently Asked Questions
What product was recalled? ▼
Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).. Recalled by Merge Healthcare, Inc.. Units affected: 1,627 sites potentially have the affected software.
Why was this product recalled? ▼
The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 5, 2017. Severity: Moderate. Recall number: Z-1681-2017.
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