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
- 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