Health product recall

Electrosurgical Generator (2017-08-18)

Starting date:
August 18, 2017
Posting date:
March 13, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-66112

Affected products

ELECTROSURGICAL GENERATOR

Reason

Olympus is taking corrective action to upgrade the software of ESG-400 units after receiving complaints that certain error codes may be generated/displayed during a procedure even though the possible causes for the error codes do not exist. When the error codes are generated, high frequency output from the ESG-400 generator is suspended, and therefore the generation of these incorrect error codes can result in a delay in the medical procedure.

Affected products

ELECTROSURGICAL GENERATOR

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number

ESG-400

Companies
Manufacturer

Olympus Winter & IBE GMBH

Kuehnstrasse 61

Hamburg

22045

GERMANY