Merge Healthcare, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1486-2017)

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.

Product Classification:

Class II

Date Initiated: April 4, 2016

Date Posted: March 29, 2017

Recall Number: Z-1486-2017

Event ID: 76431

Reason for Recall:

Cardio study list does not show STAT studies without refreshing.

Status: Terminated

Product Quantity: 217 sites potentially have the affected versions

Code Information:

Versions 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, 9.0.9, 10.0, 10.0.1, 10.1, 10.1.1, and 10.1.2.

Distribution Pattern:

Distribution was nationwide to medical facilities. There was also military distribution. There was no foreign/government distribution.

Voluntary or Mandated:

Voluntary: Firm initiated