Merge Healthcare, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1470-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 4, 2016

Date Posted: March 22, 2017

Recall Number: Z-1470-2017

Event ID: 76654

Reason for Recall:

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

Status: Terminated

Product Quantity: 187 sites potentially have the affected versions

Code Information:

iConnect Enterprise Archive versions 5.30.0 thru 9.4.3 and V11.0.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated