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