FDA 483 - GE Medical Systems Information Technologies, Inc. - July 19, 2018

GE Medical Systems Information Technologies, Inc. in Milwaukee, WI, was cited with five observations during an FDA inspection from July 9-19, 2018. The inspection revealed significant deficiencies in device software validation, design verification, medical device reporting procedures, and corrective and preventive actions. Additionally, the firm failed to accurately report the total number of devices subject to a recall.