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Complaints of software-related performance problems did not go through the firm’s complaint handling procedure, which meant they were not evaluated to determine if the events should be reported to the FDA. Read More
The procedure didn't require all service records to be evaluated for potential complaints, and the firm had not conducted the procedure since 2016. Read More
The firm’s investigation report failed to “include comments from the doctor or medical professional that the incident was not a reportable event,” the agency said. Read More
The FDA cited four devicemakers for problems with their complaint procedures, change controls and quality oversight, among other deficiencies. Read More