Health product recall

CardioLab System - Amplifier (2018-09-17)

Starting date:
September 17, 2018
Posting date:
May 8, 2020
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-73043



Last updated: 2020-05-08

Affected Products

  1. CardioLab System - Amplifier

Reason

GE healthcare has become aware that certain CLab II plus amplifiers used with Cardiolab/Combolab systems have failed the patient leakage current test.

Affected products

A. CardioLab System - Amplifier

Lot or serial number
  • RXJ19224001TA
Model or catalog number
  • 2088700-004
Companies
Manufacturer

GE Medical Systems Information Technologies, Inc.

8200 W Tower Ave

Milwaukee

53223

Wisconsin

UNITED STATES