Recall Z-1762-2017— Merge Healthcare, Inc.
Class II · Terminated
Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2016-04-04, terminated 2020-06-15. FDA's recall record names no specific 510(k) clearance for this event. Product: iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.. Reason: An error message can occur resulting in the prior studies being unavailable for viewing..
- Recalling firm
- Merge Healthcare, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-04-04
- Terminated
- 2020-06-15
- Firm location
- Hartland, WI, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.