FDA-Device2016-03-09Class II
PINPOINT Endoscopic Fluorescence Imaging System
Novadaq Technologies Inc.
Hazard
It has been determined that the PINPOINT Operator's Manual does not contain validated parameters for gravity-cycle autoclave sterilization of the PINPOINT laparoscopes and light guide cable in the reprocessing tray.
Sold states
Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Bangladesh, Canada, Hong Kong, India, and Israel.
Affected count
110 units
Manufactured in
8329 Eastlake Dr Unit 101, N/A, Burnaby, N/A, Canada
Products
PINPOINT Endoscopic Fluorescence Imaging System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1032-2016Don't want to check this manually?
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