Merge Healthcare, Inc. recalls Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.

Recalled June 21, 2017 · FDA recall Z-2590-2017 · Merge Healthcare

Hazard

Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk to health of a physician misdiagnosis because not all images are available for viewing. · FDA Class II

Units

47 sites potentially have the affected versions

Sold at

USA (nationwide) Distribution .There was no foreign/government/military distribution.

Description

Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk to health of a physician misdiagnosis because not all images are available for viewing.

Product

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

Manufacturer(s)

Merge Healthcare, Inc.

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