GEN11 Generator System - Main Unit (2018-02-20)
- Starting date:
- February 20, 2018
- 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-66134
Affected products
GENERATOR G11 SYSTEM - MAIN UNIT
Reason
Ethicon identified cybersecurity software vulnerability in the Gen11 devices that allowed bypassing of the Gen11 Security Authentication by Non-OEM (third party device) reprocessed devices.
Affected products
GENERATOR G11 SYSTEM - MAIN UNIT
Lot or serial number
All lots.
Model or catalog number
GEN11
Companies
- Manufacturer
-
ETHICON ENDO-SURGERY, LLC.
475 CALLE C
GUAYNABO
00969
PUERTO RICO