Merge Healthcare, Inc. recalls Merge OfficePACS software. The firm name on the label is Merge Healthcare, Hartland, WI. OfficePACS is intended for th

Recalled July 20, 2016 · FDA recall Z-2144-2016 · Merge Healthcare

Hazard

Potential data loss occurs as a result of the software archiving not working properly. · FDA Class II

Units

216 sites have the affected software

Sold at

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

Description

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

Product

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.

Manufacturer(s)

Merge Healthcare, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →