Z-2590-2017Class II

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

Name: Z-2590-2017 Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI
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. The firm name on the label is Merge Healthcare, Hartland, WI on 2017-05-08. FDA classified it as Class II and gives the reason as "Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk to health of a physician misdiagnosis because not all images are available for viewing". 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-2590-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-08
Posted: 2017-06-15
Terminated: 2019-08-05
Recalling firm: Merge Healthcare Incorporated
Product: Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk to health of a physician misdiagnosis because not all images are available for viewing.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: Merge Healthcare sent an Urgent Medical Device Recall letter dated May 5, 2017. The letter explains the issue and informs the customer to be aware of the workaround. The customer is also notified a software fix for the issue was released in Merge PACS 7.1.1 (or later). The customer is requested to ensure all users of the product are provided with the notification and if it has been further distributed, to notify downstream customers at once. The letter informs the customer a response is required 15 calendar days after receipt of the recall letter. The enclosed response asks, in part, if the customer is interested in accepting the fix and if not, to state the reason why. The recalling firm will contact all unresponsive customers a second and third time. Methods for contacting the customer may be by phone or email. For further questions, please call (877) 741-5369.
Quantity in commerce: 47 sites potentially have the affected versions
Distribution: USA (nationwide) Distribution .There was no foreign/government/military 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-2590-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2590-2017	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)