Company: Merge Healthcare, Inc.
Date of Enforcement Report 9/7/2016
Class lI:
PRODUCT
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.
Recall Number Z-2709-2016
REASON
A report can be confirmed with the incorrect patient demographics resulting in it being saved under the incorrect patient record in the Electronic Medical Record (EMR)..
RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 9/1/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
116 customers potentially have the affected versions
DISTRIBUTION
US Distribution to: CO and OK.
___________________________________
