
Regulatory Notices
E-6 Vicon MX Hardware System Reference
FDA Medical Device Reporting System—Reportable Events
Notice to Agents
For inclusion in all Vicon systems supplied to the United States of America (for
supply and use outside the US, see MHRA Reporting Adverse Incidents on
page E-2). The master Medical Device Reporting (MDR) file is located at Vicon
Motion Systems Limited. Should an adverse event occur, the following form
is to be completed and forwarded within one working day to Vicon Motion
Systems Limited.
Department of Health & Human Services,
US Food and Drug Administration
Medical Device Reporting System—Reportable Events
Code of Federal Regulations
Title 21, Volume 8
Revised as of April 1, 2006
Cite: 21CFG803.32
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:
Tip
You can obtain and complete an online version of the Adverse Event Report
(MEDWATCH form FDA 3500A) from the US FDA Web site (www.fda.gov/
medwatch).
Oxford
14 Minns Business Park, West Way
Oxford OX2 0JB
UK
Tel: +44 (0)1865 261800
Fax: +44 (0)1865 240527
Los Angeles
5419 McConnell Avenue
Los Angeles, CA 90066
USA
Tel: +1 310 306 6131
Fax: +1 310 437 4299
Denver
7388 S. Revere Parkway, Suite 901
Centennial, CO 80112
USA
Tel: +1 (303) 799 8686
Fax: +1 (303) 799 8690
Lake Forest
9 Spectrum Pointe Drive
Lake Forest. CA 92630
USA
Tel: +1 (949) 472 9140
Fax: +1 (949) 472 9136
MXhardware_Reference.book Page 6 Monday, April 30, 2007 1:56 PM
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