ComboLab System - Main Unit, CardioLab System - Main Unit, Mac-Lab System - Main Unit, and Mac-Lab Systems - Integrated Electronics Box (2018-06-14)
- Starting date:
- June 14, 2018
- Posting date:
- July 27, 2018
- 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-67298
Affected products
A. ComboLab System - Main Unit
B. CardioLab System - Main Unit
C. Mac-Lab System - Main Unit
D. Mac-Lab Systems - Integrated Electronics Box
Reason
The following issue is being addressed by GE healthcare file no. FMI 12269: GE Healthcare has recently become aware that the system side of the power cord may break and expose the electrical conductors leading to the risk of shock. This can lead to injuries up to and including cardiac arrhythmia or cardiac arrest.
Affected products
A. ComboLab System - Main Unit
Lot or serial number
SKP16397103TA
Model or catalog number
2092616-004
Companies
- Manufacturer
-
GE Medical Systems Information Technologies, Inc.
8200 W Tower Ave
Milwaukee
53223
Wisconsin
UNITED STATES
B. CardioLab System - Main Unit
Lot or serial number
SKP17248451TA
SKP17258483TA
SKP17258484TA
Model or catalog number
2092616-002
Companies
- Manufacturer
-
GE Medical Systems Information Technologies, Inc.
8200 W Tower Ave
Milwaukee
53223
Wisconsin
UNITED STATES
C. Mac-Lab System - Main Unit
Lot or serial number
SKP17218256TA
SKP17258477TA
SKP17258481TA
SKP17258485TA
SKP17258486TA
Model or catalog number
2092616-001
Companies
- Manufacturer
-
GE Medical Systems Information Technologies, Inc.
8200 W Tower Ave
Milwaukee
53223
Wisconsin
UNITED STATES
D. Mac-Lab Systems - Integrated Electronics Box
Lot or serial number
SG411061097GA
SPH17358709TA
SPH18049347TA
Model or catalog number
2098841-001 (2098804-001)
P1008CV (2033852-011)
Companies
- Manufacturer
-
GE Medical Systems Information Technologies, Inc.
8200 W Tower Ave
Milwaukee
53223
Wisconsin
UNITED STATES