Merge PACS and Merge OrthoPACS Recall Due to Software Issue
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 20 units of Merge PACS and Merge OrthoPACS software due to a display inaccuracy issue affecting measurements.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on September 9, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "Software issue may cause measurements to be displayed inaccurately.", distributed us nationwide distribution in the states of california, florida, kentucky, nebraska, washington.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. 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 and Merge OrthoPACS medical imaging diagnostic workstations because a software issue may cause measurements to be displayed inaccurately.
Which Products Are Affected
The recall affects Merge PACS and Merge OrthoPACS software version V9.5 with UDI (01)00842000101239(10)9.5.0(11)260409. A total of 20 units were distributed nationwide in the states of California, Florida, Kentucky, Nebraska, and Washington. The recall number is Z-3004-2026.
What You Should Do
Consumers should follow instructions provided by the recalling firm via email, fax, letter, press release, telephone, or visit.
Why This Matters
The Class II recall involves a software defect that could lead to inaccurate diagnostic measurements in medical imaging.
Source
FDA recall Z-3004-2026, event ID 99520. https://www.fda.gov
Original source: FDA Official Notice ↗
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