Merge Healthcare, Inc. recalls Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy read

Recalled December 14, 2016 · FDA recall Z-0726-2017 · Merge Healthcare

Hazard

Cut lines on the image may present horizontally rather than vertically. · FDA Class II

Units

537 sites potentially have the affected versions

Sold at

Worldwide Distribution - US (nationwide) Canada and foreign distribution

Description

Cut lines on the image may present horizontally rather than vertically.

Product

Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography.

Manufacturer(s)

Merge Healthcare, Inc.

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