Z-2379-2016Class II

Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later...

Name: Z-2379-2016 Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later...
Creator: Merge Healthcare, Inc.
Published: 2016-01-30
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2016-01-30 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI on 2016-01-30. FDA classified it as Class II and gives the reason as "The patient name in the Halo title bar and the thumbnails do not match the name on displayed images". 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-2379-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-30
Posted: 2016-08-10
Terminated: 2020-10-05
Recalling firm: Merge Healthcare Incorporated
Product: Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: The patient name in the Halo title bar and the thumbnails do not match the name on displayed images.
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm issued a letter dated 1/27/2016 via e-mail on 1/30/2016 explaining the reason for recall and instructing the customer to provide a copy of the notification to all users. A second letter was issued to nonresponders dated 5/25/2016
Quantity in commerce: 93 sites have the affected version
Distribution: The software was distributed to medical facilities nationwide. Government distribution was made to MN. Foreign distribution was made to Australia and to the United Kingdom. There was no military distribution.
Product codes and lots: Versions: V6.0.2.0 MR2 and earlier

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2379-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2379-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-10

Product code LLZ

K082144Class IIAmicas Pacs, Version 6.0Amicas, Inc. / cleared 2008-09-05

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)