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

Recall date

January 30, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2144-2016

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.