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March 2022
12 Complaints
Any serious incidents that have occurred in relation to the device should be reported to the
manufacturer.
DUNLEE
Veenpluis 6
5684 PC Best
The Netherlands
www.dunlee.com/healthcare
In the European Economic Area (EEA), the incident should also be reported to the Competent Authority
that the Member State, in which the user and/or patient is established, has designated responsible for
the implementation of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April
2017 on medical devices.
In the United States of America, the Medical Device Reporting regulation contains mandatory
requirements for manufacturers, importers, and device user facilities to report certain device related
adverse events and product problems to the FDA.
Follow the applicable laws or regulations on reporting device-related incidents or adverse events in the
jurisdiction(s) in which the system is being used.
GE Healthcare Americas
USA
800-558-5102
Canada
800-668-0732
GE Healthcare Europe
(33) 1-41-19-76-76
GE Healthcare Asia
China
86-21-62192228
Taiwan
886-2-2505-7900
Singapore
65-291-8528
Australia
61-2-9975-5501
Japan
81-120-48-2630
Korea
82-31-740-6119
India
91-80-845-2923
GE Healthcare Web Site
www.gehealthcare.com
Page 37
GE Healthcare
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