Health product recall

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