Merge Healthcare, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0878-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.

Product Classification:

Class II

Date Initiated: October 8, 2015

Date Posted: December 28, 2016

Recall Number: Z-0878-2017

Event ID: 75909

Reason for Recall:

Measurements in the software are changing after saving a plan with a measurement result, which may result in potential patient injury or delay in diagnosis or treatment.

Status: Terminated

Product Quantity: 30 sites potentially have the effected versions

Code Information:

Versions: 2.0, 2.1, 2.1.1, 3.1, 3.2, 3.2.4, 3.3, 3.3.1, 3.4, 3.5.1, 3.5.1.1, 3.5.2, 3.5.3, 3.5.4, 3.5.5, 3.6, 3.6.1, 3.6.2, 3.7, 3.7.1, 3.7.2, 3.7.2 Vet, and 3.7.3

Distribution Pattern:

Distribution was made to medical facilities in CA, CO, CT, MA, MD, MN, MT, NE, NV, NY NJ, PA, SC, WA, and WI. Foreign distribution was made to Canada, as well as other countries.

Voluntary or Mandated:

Voluntary: Firm initiated