Merge HEMO software.
Reported: August 10, 2016 Initiated: July 2, 2012 #Z-2341-2016
Product Description
Merge HEMO software.
Reason for Recall
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
Details
- Recalling Firm
- Merge Healthcare, Inc.
- Units Affected
- 37
- Distribution
- The medical facilities who currently have the affected versions are located nationwide. There was government distribution but no military or foreign distribution.
- Location
- Hartland, WI
Frequently Asked Questions
What product was recalled? ▼
Merge HEMO software.. Recalled by Merge Healthcare, Inc.. Units affected: 37.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 10, 2016. Severity: Moderate. Recall number: Z-2341-2016.
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