Merge Healthcare, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2144-2016)

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 OfficePACS software. The firm name on the label is Merge Healthcare, Hartland, WI. OfficePACS is intended for the manipulation and displaying of medical images by a suitable licensed and qualified healthcare professional. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. OrthoPACS also uses such images, in conjunction with templates for prosthetic devices, for the purposes of choosing the nature and characteristics of the prosthetic device to be used when planning a potential surgical procedure.

Product Classification:

Class II

Date Initiated: January 30, 2016

Date Posted: July 20, 2016

Recall Number: Z-2144-2016

Event ID: 74522

Reason for Recall:

Potential data loss occurs as a result of the software archiving not working properly.

Status: Terminated

Product Quantity: 216 sites have the affected software

Code Information:

Software versions: 4.0, 4.1, 4.1.1, 4.1.2, and 4.2

Distribution Pattern:

The software was distributed nationwide to medical facilities. There was no government/military/foreign distribution.

Voluntary or Mandated:

Voluntary: Firm initiated