Merge Healthcare, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1498-2017)

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 Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.

Product Classification:

Class II

Date Initiated: April 4, 2016

Date Posted: March 29, 2017

Recall Number: Z-1498-2017

Event ID: 76312

Reason for Recall:

System locks up which may result in potential patient injury or delay in diagnosis or treatment.

Status: Terminated

Product Quantity: 78 sites potentially have the affected accessory

Code Information:

Versions 1.1.2 and 1.1.3

Distribution Pattern:

Distribution was made USA (nationwide) to medical facilities. Government distribution was made. Foreign distribution was made to Canada. There was no military distribution.

Voluntary or Mandated:

Voluntary: Firm initiated