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?
If a reader selects Multi-study review prior to the original study completing its loading process and then immediately returns to image review of the original study, it is possible that not all current images will be present for review, which could result in incorrect treatment/diagnosis.
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, 9.0.8, 9.0.9, 10.0, 10.0.1, 10.1, 10.1.1, and 10.1.2
- 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
- 188 sites potentially have the effected versions
- Distribution
- US Nationwide Distribution
- Recall date
- January 25, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)