Merge Healthcare, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2715-2016)

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 RadSuite software. Radiological image processing system.

Product Classification:

Class II

Date Initiated: April 9, 2015

Date Posted: September 14, 2016

Recall Number: Z-2715-2016

Event ID: 74853

Reason for Recall:

When RadSuite is used with IPID (Issuer of Patient ID) as a part of the "Patient Identifier," it is possible in some circumstances that the demographics of one patient will be applied to a study or studies for another patient.

Status: Terminated

Product Quantity: 10 sites have the affected software that is configured with the specific conditions listed in Code Information

Code Information:

RadSuite Versions: 5.30.8, 5.35.3, 5.35.4, 5.35.5, 8.30.7.3, 8.30.7.4, 8.30.7.5, 8.30.7.7 are affected, BUT ONLY if they are configured with all of the following conditions: (1) Must have IPID enabled; (2) Must use IPID morphers (3) Must Define a Defaultvalue in the IPID Morpher; (4) Must use the Aggregating Morpher; (5) Must not set OverwritelfPresent=false; and (6) Must be on an internal store (this is data that is already present on EA being stored to Radsuite, this excludes direct DICOM stores to the EA).

Distribution Pattern:

Distribution was made to medical facilities in AL, MI, MO, PA, TN, and TX.

Voluntary or Mandated:

Voluntary: Firm initiated