- Recalling firm
- Merge Healthcare, Inc.
- Reason for recall
- Software issue may cause measurements to be displayed inaccurately.
- Affected products (lot / model / serial)
- Software version V9.5 - UDI (01)00842000101239(10)9.5.0(11)260409
- Units affected
- 20 units
- Distribution pattern
- US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.
- Firm location
- Hartland, WI, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3004-2026
- Recall initiated
- July 22, 2026
- FDA classification date
- August 21, 2026
- FDA report date
- September 2, 2026
- FDA event ID
- 99520
- Last updated on HTM Vibe
- September 8, 2026