Class IIDeviceOngoing

Merge Healthcare, Inc.

Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation

Reason for recall

Software issue may cause measurements to be displayed inaccurately.

Details

Recall number: Z-3004-2026
Event ID: 99520
Recall initiated: Jul 22, 2026
Classified: Aug 21, 2026
Reported: Sep 2, 2026
Quantity: 20 units
Distribution: US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.
Initiated by: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Firm location: Hartland, WI, United States
Lot / code info: Software version V9.5 - UDI (01)00842000101239(10)9.5.0(11)260409