Z-2715-2016Class II

Merge RadSuite software. Radiological image processing system

Name: Z-2715-2016 Merge RadSuite software. Radiological image processing system
Creator: Merge Healthcare, Inc.
Published: 2015-04-09
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2015-04-09 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of Merge RadSuite software. Radiological image processing system on 2015-04-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2715-2016
Classification: Class II
Status: Terminated
Initiated: 2015-04-09
Posted: 2016-09-02
Terminated: 2017-08-24
Recalling firm: Merge Healthcare Incorporated
Product: Merge RadSuite software. Radiological image processing system.
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm issued letters dated 4/3/2015 via email on 4/9/2015 notifying the customer of the issues.
Quantity in commerce: 10 sites have the affected software that is configured with the specific conditions listed in Code Information
Distribution: Distribution was made to medical facilities in AL, MI, MO, PA, TN, and TX.
Product codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2715-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2715-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-02

Product code LLZ

K053281Class IIEvms (Enterprise Visual Medical System Software)Emageon, Inc. / cleared 2005-12-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)