FDAFDA · Food and drugs·Recall number Z-3004-2026
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Published September 2, 2026 · Recall initiated: July 22, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Software issue may cause measurements to be displayed inaccurately.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Merge Healthcare, Inc.
- Distributor
- US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.
- Lot
- Software version V9.5 - UDI (01)00842000101239(10)9.5.0(11)260409
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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