Novadaq Technologies Inc. recalls PINPOINT Endoscopic Fluorescence Imaging System

Recall date

January 29, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1032-2016

FDA classification

Class II

Brand / firm

Novadaq Technologies Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

PINPOINT Endoscopic Fluorescence Imaging System