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Novadaq Technologies Inc. recalls PINPOINT Endoscopic Fluorescence Imaging System
Recalled March 9, 2016 · FDA recall Z-1032-2016 · Novadaq Technologies
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. · FDA Class II
Units
110 units
Sold at
Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Bangladesh, Canada, Hong Kong, India, and Israel.
Description
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.
Product
PINPOINT Endoscopic Fluorescence Imaging System
Manufacturer(s)
Novadaq Technologies Inc.
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →