Z-2303-2016Class II

Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge PACS 6.0 is...

Name: Z-2303-2016 Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge PACS 6.0 is...
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. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge PACS 6.0 is software intended to create and display... on 2016-01-30. FDA classified it as Class II and gives the reason as "A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations". 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-2303-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-30
Posted: 2016-07-29
Terminated: 2021-05-07
Recalling firm: Merge Healthcare Incorporated
Product: Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge PACS 6.0 is software intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm, Merge, issued an "URGENT: MEDICAL DEVICE RECALL" letter dated 1/27/2016 via e-mail on 1/30/2016 or via certified mail if they did not have an e-mail address for the customers. The letter described the product, problem and actions to be taken. The customers were instructed to not discontinue use of Merge PACS; to open prior comparison studies in the secondary viewer to check if there were annotations and read the report or visit note pertaining to that study to see if there are noted findings that were not otherwise apparent; to receive an upgrade call Merge Customer Service at (877) 741-5369 or send an email to [email protected] to schedule the upgrade (Reference this call #2016-010); complete the online form: http://www.merge.com/Landing-Pages/Customer-Upgrade-Decline-Form.aspx no later than 2/22/2016; If you decide to decline the maintenance release, complete the attached Customer Decline Response form and return to Merge Healthcare via [email protected], and ensure all users of the product are provided with this notification. If you have further distributed this product, identify your customers and notify them at once of this product recall. If you have any additional questions, call Merge Customer Service at (877) 741-5369 or [email protected].
Quantity in commerce: 208 sites have the affected versions
Distribution: Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Canada, Jordan, New Zealand, and the United Kingdom.
Product codes and lots: Versions: V6.5.5, 6.5.6, 6.5.7, 6.5.8, 6.5.9, 6.6.0, 6.6.1, 6.6.1.1, 6.6.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2303-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2303-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-10	2016-07-29

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)