Merge Hemo, Software packages 10.2, 10.3, and 10.4
Reported: September 8, 2021 Initiated: July 23, 2021 #Z-2387-2021
Product Description
Merge Hemo, Software packages 10.2, 10.3, and 10.4
Reason for Recall
The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x and 10.x, used in combination with an HL7 lab interface.
Details
- Recalling Firm
- Merge Healthcare, Inc.
- Units Affected
- 326 units
- Distribution
- US distribution
- Location
- Hartland, WI
Frequently Asked Questions
What product was recalled? ▼
Merge Hemo, Software packages 10.2, 10.3, and 10.4. Recalled by Merge Healthcare, Inc.. Units affected: 326 units.
Why was this product recalled? ▼
The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x and 10.x, used in combination with an HL7 lab interface.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 8, 2021. Severity: Moderate. Recall number: Z-2387-2021.
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