Z-2387-2021Class II

Merge Hemo, Software packages 10.2, 10.3, and 10.4

Name: Z-2387-2021 Merge Hemo, Software packages 10.2, 10.3, and 10.4
Creator: Merge Healthcare, Inc.
Published: 2021-07-23
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2021-07-23 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of Merge Hemo, Software packages 10.2, 10.3, and 10.4 on 2021-07-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2387-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-23
Posted: 2021-08-28
Terminated: 2023-08-29
Recalling firm: Merge Healthcare Incorporated
Product: Merge Hemo, Software packages 10.2, 10.3, and 10.4
Product code: DQK Computer, Diagnostic, Programmable
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.
Root cause tag: software
FDA root cause: Under Investigation by 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.
Quantity in commerce: 326 units
Distribution: US distribution
Product codes and lots: Version 10.2, UDI (01)00842000100430(10)10.2(11)190612 Version 10.3, UDI (01)00842000100874(10)10.3(11)200330 Version 10.4, UDI (01)00842000100966(10)10.4(11)210428

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2387-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2387-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-08	2021-08-28

Product code DQK

K152864Class IIMerge HemoMerge Healthcare Incorporated / cleared 2016-04-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)