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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Hazard
- Affected units
- 326
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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