Food, drugs, devices › Merge Healthcare, Inc.
Device recall: Merge PACS, medical imaging diagnostic workstation
Merge Healthcare, Inc. (Hartland, WI) initiated this device recall on 30 Jun 2026; FDA lists 2 product records under event 99391, classified Class II.
FDA defines Class II as 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. 87% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Merge Healthcare, Inc. has 84 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Merge Healthcare, Inc., Hartland, WI.
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2874-2026 | Merge PACS, medical imaging diagnostic workstation | 53 units | Class II | Ongoing | 12 Aug 2026 |
| Z-2875-2026 | Merge OrthoPACS, medical imaging diagnostic workstation | 5 units | Class II | Ongoing | 12 Aug 2026 |
Context
Other enforcement events for Merge Healthcare, Inc.
All 84 events for Merge Healthcare, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide and the countries of Canada, and UK."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.