4. The Medical Device Vigilance System imposes on manufacturers the duty to promptly
report to Competent Authorities in case a medical device made by the manufacturer has
caused an incident that led to a serious deterioriation of the state of health of a patient or
user.
In the improbable event that your XO ODONTOSURGE should be involved in such an inci-
dent, it is therefore very important that you:
1. Promptly inform XO CARE A/S,
2. immediately stop using the unit, and
3. immediately store the unit separately and exactly in the condition it was in, i.e. without any
kind of cleaning or disassembling.
17
