Z-2601-2017Class II

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

Name: Z-2601-2017 Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI
Creator: Merge Healthcare, Inc.
Published: 2017-05-24
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2017-05-24 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI on 2017-05-24. 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-2601-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-24
Posted: 2017-06-16
Terminated: 2019-10-15
Recalling firm: Merge Healthcare Incorporated
Product: Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
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 (manufacturing process)
Action: Merge Healtcare sent an Urgent Medical Device Recall letter dated May 19, 2017, via email on May 24, 2017. The letter notifies the customer of the issue, informs them to be aware of the workaround, and that a fix is available for the issue in Merge OrthoPACS 6.6.3.2 (or later). 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 15 calendar days after receipt of the recall letter using the enclosed form. 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 recalling firm will contact all unresponsive customers with a second customer letter, followed by a third customer letter. They may additionally contact customers that are unresponsive via telephone. For further questions, please call ( 877) 741-5369.
Quantity in commerce: 160 sites potentially have the affected versions
Distribution: USA (nationwide) Distribution was made to medical facilities. There was no foreign/government/military distribution.
Product codes and lots: Versions 6.6, 6.6.1, 6.6.2, 6.6.2.1, and 6.6.2.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2601-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2601-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-28	2017-06-16

Product code LLZ

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)