FDA-Device2021-09-08Class II
Merge Hemo, Software packages 10.2, 10.3, and 10.4
Merge Healthcare, Inc.
Hazard
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.
Sold states
US distribution
Affected count
326 units
Manufactured in
900 Walnut Ridge Dr, N/A, Hartland, WI, United States
Products
Merge Hemo, Software packages 10.2, 10.3, and 10.4
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2387-2021Don't want to check this manually?
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