Company: Merge Healthcare, Inc.
Date of Enforcement Report 12/28/2016
Class lI:
PRODUCT
Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI..
Recall Number Z-0878-2017
REASON
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.
RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 10/8/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT 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.
___________________________________
