08
Sep
2021

Recall – Safety issue identified with cath lab software

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Company: Merge Healthcare, Inc.
Date of Enforcement Report: 9/8/2021
Class II

PRODUCT

Merge Hemo, Software packages 10.2, 10.3, and 10.4

Recall Number: Z-2387-2021

REASON

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.

RECALLING FIRM/MANUFACTURER

Merge Healthcare, Inc. on 7/23/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

326 units

DISTRIBUTION

U.S. Nationwide

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