iConnect Enterprise Archive when used with RadSuite. recall: Software Issue
iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare.
Why was iConnect Enterprise Archive when used with RadSuite. recalled?
The software produced a number of "do not route" exceptions, which may result in potential patient injury or delay in diagnosis or treatment.
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?
iConnect Enterprise Archive versions 5.30.0 thru 9.4.3 and V11.0.
- Product
- iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare.
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 187 sites potentially have the affected versions
- Distribution
- USA (nationwide ) Distribution to medical facilities. Government distribution was also made. There was no foreign or military distribution.
- Recall date
- March 22, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)