Summary
The FDA issued a Class II for Merge PACS, medical imaging diagnostic workstation by Merge Healthcare, Inc.. Reason: Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open..
Details
Source
Device Recall
External ID
Z-2874-2026
Action Date
2026-08-12
Status
Ongoing
Category
device
Product Description
Merge PACS, medical imaging diagnostic workstation
Lot/Code Info: UDI (01)00842000101215(10)9.4.0.P01(11)250916, (01)00842000101154(10)9.4.0.P02(11)260302 with Affected Versions: 9.4, 9.4 P01, and 9.4 P02.
Quantity Affected: 53 units
Reason for Recall
Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, and UK.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-30
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 156 device recalls issued in the same week, part of 400 device-related FDA actions this month.
Merge Healthcare, Inc. has 9 FDA actions in our database, including 9 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 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2874-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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