System information

Vicon MX Hardware System Reference E-1
E
ERegulatory Notices
This appendix provides required regulatory notices regarding the
supply and use of Vicon MX.
Notice to Agents
For inclusion in all Vicon systems supplied to the United States of
America. The master Medical Device Reporting (MDR) file is located
at Vicon Motion Systems Limited. Should an adverse event occur, the
following completed form (fdamdr.doc) is to be forwarded within one
working day to Vicon Motion Systems Limited.
Department of Health & Human Services, Food and Drug
Administration
Medical Device Reporting System - Reportable Events
Effective from 3rd September 1996
Reference: A. 21 Code of Federal Regulations Part 803
Under 803.1(a) device user facilities and manufacturers must report
deaths and serious injuries to which a device has or may have caused
or contributed. Should such an event occur, please complete the
following details and forward the document in accordance with the
applicable regulations and time limits to one of the following
addresses:
Oxford
14 Minns Business Park, West Way
Oxford OX2 0JB
UK
Tel: [phone]
Fax: [phone]
Los Angeles
5419 McConnell Avenue
Los Angeles, CA 90066
USA
Tel: [phone]
Fax: [phone]
Denver
7388 S. Revere Parkway, Suite 901
Centennial, CO 80112
USA
Tel: [phone]
Fax: [phone]
Lake Forest
9 Spectrum Pointe Drive
Lake Forest. CA 92630
USA
Tel: [phone]
Fax: [phone]
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