Merge Healthcare, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2387-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Merge Hemo, Software packages 10.2, 10.3, and 10.4

Product Classification:

Class II

Date Initiated: July 23, 2021

Date Posted: September 8, 2021

Recall Number: Z-2387-2021

Event ID: 88379

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.

Status: Terminated

Product Quantity: 326 units

Code Information:

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

Distribution Pattern:

US distribution

Voluntary or Mandated:

Voluntary: Firm initiated