Merge Cardio software. Merge Cardio is a system recall
Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including…
Why was Merge Cardio software. Merge Cardio is a system recalled?
If images are sent without an order in the system, they will be matched with the latest order on the current patient/modality matching potentially resulting in the matching of the report to the incorrect accession number (but still associated to the correct patient).
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: 8.30.0, 8.30.1, 9.0, 9.0.1, 9.0.2, 9.0.3, 9.0.4, 9.0.5, 9.0.6, 9.0.7, 9.0.8, 9.0.9, 10.0, 10.0.1, 10.1, and 10.1.1
- Product
- Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including…
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 198 sites potentially have the effected versions
- Distribution
- Nationwide Distribution
- Recall date
- December 21, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)