Merge Healthcare, Inc.: Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Merge Healthcare, Inc.
- Product
- Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
- Reason / hazard
- Software issue may cause measurements to be displayed inaccurately.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.
- Recall initiated
- 2026-07-22
- Code info
- Software version V9.5 - UDI (01)00842000101239(10)9.5.0(11)260409
- Product quantity
- 20 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Hartland
- State
- WI
- Country
- United States
- Event id
- 99520
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