Z-0878-2017Class II

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

Name: Z-0878-2017 Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI
Creator: Merge Healthcare, Inc.
Published: 2015-10-08
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2015-10-08 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI on 2015-10-08. FDA classified it as Class II and gives the reason as "Measurements in the software are changing after saving a plan with a measurement result, 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-0878-2017
Classification: Class II
Status: Terminated
Initiated: 2015-10-08
Posted: 2016-12-21
Terminated: 2018-06-22
Recalling firm: Merge Healthcare Incorporated
Product: Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Measurements in the software are changing after saving a plan with a measurement result, which may result in potential patient injury or delay in diagnosis or treatment.
Root cause tag: software
FDA root cause: Software design
Action: Merge issued a letter dated March 28, 2016, via email on April 4, 2016, or via certified mail if they did not have an email address for the customer. The letter notifies the customer of the issue, informs them of a workaround and that a fix is not yet available but they will be notified once one 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. Nonresponders were issued a second letter dated July 11, 2016, asking for a response by August 2, 2016. For further questions, please call (877) 741-5369.
Quantity in commerce: 30 sites potentially have the effected versions
Distribution: Distribution was made to medical facilities in CA, CO, CT, MA, MD, MN, MT, NE, NV, NY NJ, PA, SC, WA, and WI. Foreign distribution was made to Canada, as well as other countries.
Product codes and lots: Versions: 2.0, 2.1, 2.1.1, 3.1, 3.2, 3.2.4, 3.3, 3.3.1, 3.4, 3.5.1, 3.5.1.1, 3.5.2, 3.5.3, 3.5.4, 3.5.5, 3.6, 3.6.1, 3.6.2, 3.7, 3.7.1, 3.7.2, 3.7.2 Vet, and 3.7.3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0878-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0878-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-21

Product code LLZ

K022881Class IICedara I-SoftviewCedara Software Corp. / cleared 2002-10-22

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)