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

FDA device recall Z-0878-2017 · posted 2016-12-21 · Terminated

Recall details

Recalling firm

Merge Healthcare, Inc.

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.

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

LLZ

Quantity affected

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.

Date initiated

2015-10-08

Date posted

2016-12-21

Date terminated

2018-06-22

Location

Hartland, WI

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