Z-1180-2017Class II

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

Name: Z-1180-2017 Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI
Creator: Merge Healthcare, Inc.
Published: 2015-11-17
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2015-11-17 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI on 2015-11-17. FDA classified it as Class II and gives the reason as "The values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or 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-1180-2017
Classification: Class II
Status: Terminated
Initiated: 2015-11-17
Posted: 2017-02-09
Terminated: 2017-02-10
Recalling firm: Merge Healthcare Incorporated
Product: Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: The values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis or treatment.
Root cause tag: software
FDA root cause: Software design
Action: Merge sent an Urgent Medical Device Recall letter dated March 28, 2016 to all affected customers. The letter notifies the customer of the issue and informs them an upgrade is available. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. The notification also informs the customer their response is required using the enclosed form and the return addressed envelope. The response form asks, in part, if they are interested in accepting the fix. If they decline the fix, they are asked to provide the reason why. The response was required no later than April 18, 2016. A second letter dated July 11, 2016, was issued asking for a response by August 2, 2016, even though all upgrades were made because the effectiveness checks were not yet completed. The letter and response form contained the same information as the first letter. The recalling firm reported emails were tracked for delivery confirmation and the letters were tracked for delivery by USPS certified services. For further questions, please call 877-744-5369.
Quantity in commerce: 8 sites have the potentially affected version
Distribution: US Distribution was made to medical facilities in AL, IN, MI, PA and WI.
Product codes and lots: Version V8.30.7.8

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1180-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1180-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-15	2017-02-09

Product code LLZ

K053281Class IIEvms (Enterprise Visual Medical System Software)Emageon, Inc. / cleared 2005-12-07

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)