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Health product recall

PINPOINT Endoscopic Fluorescence Imaging System (Operator Manual) (2016-01-29)

Starting date:
January 29, 2016
Posting date:
May 25, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-57104

Affected Products

  1. PINPOINT Endoscopic Fluorescence Imaging System (Operator Manual)

Reason

Operator manual is being recalled since it does not contain validated parameters for gravity-cycle autoclave sterilization of the PINPOINT laparoscopes and light guide cable in the reprocessing tray.

Affected products

  1. PINPOINT Endoscopic Fluorescence Imaging System (Operator Manual)

Lot or serial number

Manual Rev. B,C,D,E

Model or catalog number

PC9000

Companies
Manufacturer
NOVADAQ TECHNOLOGIES INC.
8329 Eastlake Drive, Unit 101
Burnaby
V5A 4W2
CANADA