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Health product recall

Video Telescope

Starting date:
February 21, 2017
Posting date:
March 24, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-62752

Reason

Olympus has initiated this recall after discovering that the ENDOEYE distal end can become abnormally hot if the temperature sensor at the device's tip is damaged. Although no customer complaints have been received referring to this issue and thus manufacturer is not aware of any patient or user injury, excessive heating of the ENDOEYE distal end could result in patient or user injury. To prevent a potential risk to patient or user health, Olympus is undertaking this action to repair the devices by disabling a specific feature on the video telescopes ("fog-free function") to prevent excessive heating of the ENDOEYE distal end under certain conditions.

Affected products

Video Telescope

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

WA50040A
WA50042A

Companies

Manufacturer
Olympus Winter & IBE GMBH
Kuehnstrasse 61
Hamburg
22045
GERMANY