Z-2363-2016Class II

Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create...

Name: Z-2363-2016 Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create...
Creator: Merge Healthcare, Inc.
Published: 2016-02-05
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2016-02-05 / 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, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional... on 2016-02-05. FDA classified it as Class II and gives the reason as "When measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the Hologic imager (different image), the measurements are not the same". 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-2363-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-05
Posted: 2016-08-08
Terminated: 2016-10-25
Recalling firm: Merge Healthcare Incorporated
Product: Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. 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: When measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the Hologic imager (different image), the measurements are not the same.
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm's customer support notified customers via phone call beginning 2/5/2016 to inform them of the issue. Customers were informed that a software fix that corrects the issue was available. Customers were asked not to use the measurements on mammo images until upgraded. If customers want an upgrade, then someone would contact them to schedule the upgrade.
Quantity in commerce: 49 sites potentially have the affected versions
Distribution: Worldwide Distribution -- USA and Australia.
Product codes and lots: Software versions 6.0.2.0 MR2, 6.0.3.0 MR3, 6.0.3.1 MR3 CU1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2363-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2363-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-08

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)