Z-1385-2017Class II

DR Systems Unity PACS software, now known as Merge Unity PACS

Name: Z-1385-2017 DR Systems Unity PACS software, now known as Merge Unity PACS
Creator: Merge Healthcare, Inc.
Published: 2016-04-08
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2016-04-08 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and information management system that allows... on 2016-04-08. FDA classified it as Class II and gives the reason as "The software is not adding the correct tomo image". 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-1385-2017
Classification: Class II
Status: Terminated
Initiated: 2016-04-08
Posted: 2017-03-02
Terminated: 2017-03-06
Recalling firm: Merge Healthcare Incorporated
Product: DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS 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 adding the correct tomo image.
Root cause tag: software
FDA root cause: Software design
Action: Merge sent an Urgent Medical Device Recall dated July 11, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions send an email to [email protected]
Quantity in commerce: 28 sites potentially have the affected software
Distribution: US Nationwide Distribution in the states of AL CA, CO, FL, IL, MD, MN, MT, NV, NY, OR, PA SC, TN, and TX.
Product codes and lots: Versions 11.0 and 11.0.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1385-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1385-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-08	2017-03-01

Product code LLZ

K041935Class IIDr Systems Pacs, Release 6.1Dr Systems, Inc. / cleared 2004-08-16

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)