Device recall
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
- Recall number
- Z-3004-2026
- Event id
- 99520
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Merge Healthcare, Inc.
- Report date
- Sep 2, 2026
- Posted
- Aug 21, 2026
- Initiated
- Jul 22, 2026
- Center classification date
- Aug 21, 2026
- Product code
- LLZ
- Device type
- System, Image Processing, Radiological
- Reason
- Software issue may cause measurements to be displayed inaccurately.
- Root cause
- Software Design Change
- Quantity
- 20 units
- Code info
- Software version V9.5 - UDI (01)00842000101239(10)9.5.0(11)260409
- Distribution
- US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K192455
- Location
- Hartland, WI, United States