The Recall Desk
HighFDA (Devices)·Z-2387-2021·Announced 2021-09-08

Merge Hemo Software Recall Due to HL7 Lab Interface Safety Issue

Merge Healthcare recalls Merge Hemo software versions 10.2, 10.3, and 10.4. The safety issue affects versions 9.x and 10.x when used with HL7 lab interfaces. No illnesses or injuries reported.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall identifying a software safety issue affecting healthcare functionality with no reported illnesses or injuries. It meets the rubric criterion for High severity as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Merge Healthcare, Inc. is recalling Merge Hemo software packages versions 10.2, 10.3, and 10.4 (approximately 326 units distributed in the United States). The U.S. Food and Drug Administration classified this as a Class II recall.

The company identified a safety issue affecting Merge Hemo software versions 9.x and 10.x when used in combination with HL7 lab interfaces. The specific nature of the safety issue is not detailed in the available recall information.

No illnesses or injuries related to this issue have been reported.

The recalled product

Product
Merge Hemo, Software packages 10.2, 10.3, and 10.4
Manufacturer
Merge Healthcare, Inc.
Category
Medical Device — Healthcare Software / HL7 Interface
Hazard
  • software-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • 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

Distribution scope not specified by the agency.

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