PINPOINT Endoscopic Fluorescence Imaging System

Reason: 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.

Code information: Rev. J, Rev. K, Rev. L and Rev. M Model Number : PC9000

Distribution pattern: Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Bangladesh, Canada, Hong Kong, India, and Israel.