Z-2566-2018Class II

Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge...

Name: Z-2566-2018 Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge...
Creator: Merge Healthcare, Inc.
Published: 2017-08-07
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2017-08-07 / Terminated / root cause: manufacturing process

FDA source

Merge Healthcare, Inc. began a recall of Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical... on 2017-08-07. FDA classified it as Class II and gives the reason as "The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2566-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-07
Posted: 2018-10-11
Terminated: 2020-05-18
Recalling firm: Merge Healthcare Incorporated
Product: Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: MERGE sent a Medical Device Recall letter on about 08/07/2017, to all affected customers. Customers were advised to discontinue using the affected product and to reply using the enclosed form. Customers with questions were instructed to send an email to [email protected]. For questions regarding this recall call 262-912-3514.
Quantity in commerce: 11 sites have potentially affected software
Distribution: Nationwide distribution to CA, KY, ME, OH, OR, TN, TX, WA, WV.
Product codes and lots: Software versions 10.0.6 and 10.0.7. Only customers with these 2 versions AND a license for Mammo Tracking are impacted by this recall.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2566-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2566-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-27

Product code LLZ

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)