Merge Healthcare, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0729-2017)

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. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.

Product Classification:

Class II

Date Initiated: March 28, 2016

Date Posted: December 21, 2016

Recall Number: Z-0729-2017

Event ID: 75825

Reason for Recall:

If images are sent without an order in the system, they will be matched with the latest order on the current patient/modality matching potentially resulting in the matching of the report to the incorrect accession number (but still associated to the correct patient).

Status: Terminated

Product Quantity: 198 sites potentially have the effected versions

Code Information:

Versions: 8.30.0, 8.30.1, 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, and 10.1.1

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated