Z-1176-2017Class II

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

Name: Z-1176-2017 Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI
Creator: Merge Healthcare, Inc.
Published: 2016-04-04
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2016-04-04 / 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 2016-04-04. FDA classified it as Class II and gives the reason as "Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment". 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-1176-2017
Classification: Class II
Status: Terminated
Initiated: 2016-04-04
Posted: 2017-02-09
Terminated: 2019-04-08
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: Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment.
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm issued a letter dated 3/28/2016 via email on 4/4/2016 or via certified mail if they did not have an email address for the customer. A second letter was issued 7/11/2016 to nonresponders.
Quantity in commerce: 29 sites have the potentially affected software
Distribution: Distribution was made to medical facilities in AZ, CA, CO, FL, HI, IL, MA, MD, MI, MO, NY, OH, PA, SC, TN, UT, and WI. There was no foreign/government/military distribution.
Product codes and lots: Version 7.0.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1176-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1176-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-15	2017-02-09

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)