Merge HEMO software recall
Merge HEMO software.
Why was Merge HEMO software recalled?
The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7
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?
Software versions 8.10, 9.10, 9.20.
- Product
- Merge HEMO software.
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 37
- Distribution
- The medical facilities who currently have the affected versions are located nationwide. There was government distribution but no military or foreign distribution.
- Recall date
- August 10, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)