Merge Healthcare, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1180-2017)

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:

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

Product Classification:

Class II

Date Initiated: November 17, 2015

Date Posted: February 15, 2017

Recall Number: Z-1180-2017

Event ID: 76258

Reason for Recall:

The values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis or treatment.

Status: Terminated

Product Quantity: 8 sites have the potentially affected version

Code Information:

Version V8.30.7.8

Distribution Pattern:

US Distribution was made to medical facilities in AL, IN, MI, PA and WI.

Voluntary or Mandated:

Voluntary: Firm initiated