Product Safety Recalls

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Merge Healthcare, Inc. Recall 88379

Description: Merge Hemo, Software packages 10.2, 10.3, and 10.4

Merge Healthcare, Inc. Recall 88379 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-2387-2021
Event ID88379
Event DescriptionMerge Hemo, Software packages 10.2, 10.3, and 10.4
Product TypeDevices
DistributionUS distribution
Quantity326 units
Recall ReasonThe 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.
Device Classification20210908
Device Code InfoVersion 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
Center Classification Date20210828
Recall Initiation Date20210723
Recalling FirmMerge Healthcare, Inc.
Initial Notification E-Mail
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