Z-2551-2016Class II

Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image and information...

Name: Z-2551-2016 Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image and information...
Creator: Merge Healthcare, Inc.
Published: 2015-07-23
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2015-07-23 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing, selection... on 2015-07-23. FDA classified it as Class II and gives the reason as "The software is unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm". 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-2551-2016
Classification: Class II
Status: Terminated
Initiated: 2015-07-23
Posted: 2016-08-16
Terminated: 2016-10-07
Recalling firm: Merge Healthcare Incorporated
Product: Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems 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 unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm.
Root cause tag: software
FDA root cause: Software design
Action: The firm, Merge, sent a "canned" email on 7/23/2015 to its customers which also contained a personal message. The recalling firm issued a second letter entitled "URGENT: MEDICAL DEVICE RECALL" dated 1/27/2016 via e-mail on 1/30/2016. The letters described the product, problem and actions to be taken. The letter informed customers that an upgrade is available. The customers were instructed to call Merge Customer Service at (877) 741-5369 or send an email to [email protected] to schedule the upgrade-Reference this recall #2016-14. If you decide to decline this maintenance release, complete the attached form and return to Merge Healthcare via [email protected]. Alternatively, complete the online form: http://www.merge.com/Landing-Pages/Customer-Upgrade-Decline-Form.aspx no later than February 22, 2016. Ensure that all users of the product are provided with this notification. If you have further distributed this, identify your customers and notify them at once of this product recall and provide a copy of the recall notification letter. If you have any additional questions, call Merge Customer Service at (877) 741-5369 or [email protected].
Quantity in commerce: 9 sites potentially have the affected version
Distribution: US Distribution to states of: CA, PA, TX, and MT.
Product codes and lots: Version 11.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2551-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2551-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-16

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)