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Terminated

Merge Hemo, Software packages 10.2, 10.3, and 10.4

FDA Recall Z-2387-2021 · Posted None

Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeDQK
Date Initiated2021-07-23
Date Terminated2023-08-29
Product Quantity326 units

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.

Firm Action

The firm issued an Urgent Field Safety Notice by email on 07/23/2021. The letter explained the issue and provided a workaround for the safe, continued use of the instrument until a software correction can be made.

Root Cause

Under Investigation by firm

Distribution Pattern

US distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K152864Merge HemoMerge Healthcare Incorporated · 2016-04-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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