iConnect Enterprise Archive. The firm name on the label recall
iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, Hartland, WI. iConnect Enterprise Archive is intended for use as a vendor…
Why was iConnect Enterprise Archive. The firm name on the label recalled?
Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite.
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?
Version: 8.80, 8.80.0.1, 8.80.0.2, 8.80.1.1, 8.80.2, and 8.80.2.1
- Product
- iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, Hartland, WI. iConnect Enterprise Archive is intended for use as a vendor…
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 96 sites potentially have the affected versions for both products
- Distribution
- US Distribution to: CO and OK.
- Recall date
- September 7, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)