Merge Cardio software using EchoIMS. The firm name on recall
Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
Why was Merge Cardio software using EchoIMS. The firm name on recalled?
A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving the read-only notification prompt.
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 9.0.9 and earlier using EchoIMS.
- Product
- Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 17 sites potentially have the affected versions
- Distribution
- US Distribution was made to medical facilities in CA, FL, IL, MD, MO, OH, OK, TX, VT, and WI. Military distribution was also made.
- Recall date
- March 29, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)