iConnect Enterprise Archive recall
iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.
Why was iConnect Enterprise Archive recalled?
An error message can occur resulting in the prior studies being unavailable for viewing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Versions : 8.30, 8.30.2, 8.40.0, 8.40.1, 8.40.1 HF0557, 8.40.s, 8.40.2.1, 8.40.2.2, 8.80, 8.80.0.1, 8.80.1.1, 8.80.2, 8.80.0.2, 9.0.0, 9.0.0.1, 9.1.0, 9.1.1, 9.1.2, 9.1.2.1, 9.1.2.2, 9.2.0, 9.3.0, 9.3.1, 9.4.0, 9.4.1, 9.4.2, 9.4.2.1., and 9.4.3
- Product
- iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 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.
- Recall date
- April 19, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)