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EndoEye HD II Video Telescope (2015-11-19)
- Starting date:
- November 19, 2015
- 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-56208
Affected Products
EndoEye HD II Video Telescope
Reason
Manufacturer initiated removal action of ENDOEYE HD II Video Telescope following a complaint from outside of Canada and U.s of a damaged temperature sensor at the ENDOEYE tip which caused the distal end to become abnormally hot. Although no patient or user injury occurred as a result of this reported complaint, excessive heating of the ENDOEYE distal end could result in patient or user injury.
Affected products
EndoEye HD II 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