Z-2591-2017Class II

Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft...

Name: Z-2591-2017 Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft...
Creator: Merge Healthcare, Inc.
Published: 2017-05-08
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2017-05-08 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies... on 2017-05-08. FDA classified it as Class II and gives the reason as "When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician. This may cause a misdiagnosis". 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-2591-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-08
Posted: 2017-06-15
Terminated: 2019-08-08
Recalling firm: Merge Healthcare Incorporated
Product: Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography
Product code: LLZ System, Image Processing, Radiological
Reason for recall: When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician. This may cause a misdiagnosis.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: Merge sent an Urgent Medical Device Recall letter dated May 5, 2017, to all affected customers. Customers were instructed to be aware of the following workaround: Do not have the simple close study red x icon available in the reading physicians toolbars. This will force them to set status on close which also presents the warning Not all images have been reviewed, do you want to set status anyway and close study or continue reviewing unviewed images? YOUR RESPONSE TO THIS NOTIFICATION IS REQUIRED By replying to this notification, you will be taking the necessary steps to ensure that the issue listed in this document will be resolved. Please reply using the enclosed form and the return addressed envelope. Customers with questions were instructed to send an email to [email protected]. For questions regarding this recall call 877-741-6369.
Quantity in commerce: 47 sites have the potentially affected versions
Distribution: Nationwide Distribution
Product codes and lots: Versions 7.0.2.1, 7.0.2.2, 7.0.2.3, 7.0.2.3 P1, and 7.0.2.3 P2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2591-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2591-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-15

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)