Merge Healthcare, Inc. recalls iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare.

Recalled March 22, 2017 · FDA recall Z-1470-2017 · Merge Healthcare

Hazard

The software produced a number of "do not route" exceptions, which may result in potential patient injury or delay in diagnosis or treatment. · FDA Class II

Units

187 sites potentially have the affected versions

Sold at

USA (nationwide ) Distribution to medical facilities. Government distribution was also made. There was no foreign or military distribution.

Description

The software produced a number of "do not route" exceptions, which may result in potential patient injury or delay in diagnosis or treatment.

Product

iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare.

Manufacturer(s)

Merge Healthcare, Inc.

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