Recall Z-1032-2016— Novadaq Technologies Inc.

Name: FDA recall Z-1032-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-29

Class II · Terminated

Class II FDA medical device recall by Novadaq Technologies Inc., initiated 2016-01-29, terminated 2016-11-03. It names one FDA 510(k) clearance: K091515. Product: 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..

Recalling firm: Novadaq Technologies Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-01-29
Terminated: 2016-11-03
Firm location: Burnaby, N/A, Canada

510(k) clearances named in this recall

1 on FDA's record

K091515 — SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEMNovadaq Technologies, Inc.·cleared 2009-07-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

PINPOINT Endoscopic Fluorescence Imaging System

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.