iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.
Reported: April 19, 2017 Initiated: April 4, 2016 #Z-1762-2017
Product Description
iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.
Reason for Recall
An error message can occur resulting in the prior studies being unavailable for viewing.
Details
- Recalling Firm
- Merge Healthcare, Inc.
- Units Affected
- 333 sites potentially have the affected versions
- Distribution
- Distribution was made nationwide to medical facilities. Foreign distribution was made to Canada, as well as other countries. Government/military distribution was also made.
- Location
- Hartland, WI
Frequently Asked Questions
What product was recalled? ▼
iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.. Recalled by Merge Healthcare, Inc.. Units affected: 333 sites potentially have the affected versions.
Why was this product recalled? ▼
An error message can occur resulting in the prior studies being unavailable for viewing.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 19, 2017. Severity: Moderate. Recall number: Z-1762-2017.
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