Merge Cardio software. Product Usage: Merge Cardio is a recall
Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical…
Why was Merge Cardio software. Product Usage: Merge Cardio is a recalled?
Users can merge a device import file with an image study that already has a confirmed report, which may result in including information not present at the time of physician interpretation.
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 9.0, 9.0.1, 9.0.2, 9.0.3, 9.0.4, 9.0.5, 9.0.6, 9.0.7, and 9.0.8
- Product
- Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical…
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 89 sites potentially have the affected software
- Distribution
- US Nationwide Distribution.
- Recall date
- March 29, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)