Z-1431-2017Class II

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

Name: Z-1431-2017 Merge PACS software. The firm name on the label is Merge Healthcare
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 on 2016-04-04. FDA classified it as Class II and gives the reason as "Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server". 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-1431-2017
Classification: Class II
Status: Terminated
Initiated: 2016-04-04
Posted: 2017-03-09
Terminated: 2021-04-23
Recalling firm: Merge Healthcare Incorporated
Product: Merge PACS software. The firm name on the label is Merge Healthcare.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.
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 via email the week of April 4, 2016. If no email address was available, the letters were issued via certified mail. A letter dated February 21, 2017 , was issued was also issued via email or certified mail. The letter notifies the customer of the issue, informs them not receiving updated demographics or image content may result in delay in diagnosis or treatment of the patient or misdiagnosis, and they should be aware of the workaround. The customer is also notified a fix is not yet available, however, the recalling firm is working on correcting the issue and will inform them once a fix is made 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 understand the workaround and are they 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 was issued dated February 21, 2017,via email or certified mail if no email address was available. The letter notified customers a fix was now available and also contained the same information and response form as the first letter. The letter informed the customer a response was required 15 calendar days after receipt of the letter. The recalling firm reported emails will be tracked for delivery confirmation and the letters will be tracked for delivery by USPS certified services. For further questions, please call (877) 741-5369.
Quantity in commerce: 248 sites potentially have the affected versions
Distribution: USA (nationwide ) Distribution was made to medical facilities. Internationally to Canada. There was no government or military distribution.
Product codes and lots: Versions 6.6.1, 6.6.1.1, 6.6.2, 6.6.2.1, 6.6.2.2, 7.0, and 7.0.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1431-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1431-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-09

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)