Merge Healthcare, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1496-2017)

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 Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.

Product Classification:

Class II

Date Initiated: September 22, 2015

Date Posted: March 29, 2017

Recall Number: Z-1496-2017

Event ID: 76717

Reason for Recall:

For sites using the Issuer of Patient ID (IPID), the system will display the study list and images from different patients with different IPIDs as though they are for the same patient if they all have the first name, last name, and medical record number in common.

Status: Terminated

Product Quantity: 16 sites were originally identified as potentially having the affected versions

Code Information:

Versions 8.30, 9.0, 9.0.1, 9.0.2, 9.0.3, 9.0.4, 9.0.5, 9.0.6, 9.0.7, 9.0.8, 10.0, 10.0.1, and 10.1 with Issuer of Patient ID (IPID)

Distribution Pattern:

US Distribution was made to medical facilities located in GA, IL, MD, MI, MO, OH, TN, and VT. There was no foreign/government/military distribution.

Voluntary or Mandated:

Voluntary: Firm initiated