Merge Healthcare, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2865-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system.

Product Classification:

Class II

Date Initiated: January 30, 2016

Date Posted: September 28, 2016

Recall Number: Z-2865-2016

Event ID: 75034

Reason for Recall:

Patient information in the header is only found on the first page of the report and not on the subsequent pages.

Status: Terminated

Product Quantity: 42 sites potentially have the affected version

Code Information:

Version 10.1

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated