Merge Healthcare, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2341-2016)

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 HEMO software.

Product Classification:

Class II

Date Initiated: July 2, 2012

Date Posted: August 10, 2016

Recall Number: Z-2341-2016

Event ID: 74577

Reason for Recall:

The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7

Status: Terminated

Product Quantity: 37

Code Information:

Software versions 8.10, 9.10, 9.20.

Distribution Pattern:

The medical facilities who currently have the affected versions are located nationwide. There was government distribution but no military or foreign distribution.

Voluntary or Mandated:

Voluntary: Firm initiated