Merge PACS Medical Imaging Workstation Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Merge Healthcare, Inc. is recalling 53 units of Merge PACS due to a software issue displaying thumbnails from a previously opened patient study.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 19, 2026 and geographically references Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-devices.
What Happened
Merge Healthcare, Inc. initiated a voluntary recall of Merge PACS because thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.
Which Products Are Affected
The recall affects Merge PACS, medical imaging diagnostic workstation, with UDI (01)00842000101215(10)9.4.0.P01(11)250916, (01)00842000101154(10)9.4.0.P02(11)260302 and affected versions 9.4, 9.4 P01, and 9.4 P02. A total of 53 units are involved. Distribution is worldwide, including US nationwide, Canada, and the UK.
What You Should Do
Contact Merge Healthcare, Inc. for additional information regarding the recall.
Why This Matters
The software issue could lead to display of incorrect patient study information during diagnostic imaging review.
Source
FDA recall number Z-2874-2026, event ID 99391. Classification: Class II.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (903 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 19, 2026.
Frequently Asked Questions
Common questions about this FDA recall.