Summary
The FDA issued a Class II for Merge Hemo, Software packages 10.2, 10.3, and 10.4 by Merge Healthcare, Inc.. Reason: 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 interf.
Details
Source
Device Recall
External ID
Z-2387-2021
Action Date
2021-09-08
Status
Terminated
Category
device
Product Description
Merge Hemo, Software packages 10.2, 10.3, and 10.4
Lot/Code Info: 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
Quantity Affected: 326 units
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.
Distribution
US distribution
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-23
Company
Hartland, WI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 126 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Merge Healthcare, Inc. has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Merge Healthcare, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Merge Healthcare, Inc. have FDA actions?
Merge Healthcare, Inc. has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2387-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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