Health product recall

Optima CT540 Series CT Scanner System (2018-04-27)

Starting date:
April 27, 2018
Posting date:
July 19, 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-67276

Affected products

Optima CT540 Series CT Scanner System

Reason

The following issue is being addressed by GE healthcare file no. FMI 26859: GE healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC (volts alternating current) to service engineers working inside the gantry. This issue does not affect patients or operators external to the equipment.

Affected products

Optima CT540 Series CT Scanner System

Lot or serial number

00000332406HM8
CBAQG1600070HM
CBAQG1700017HM

Model or catalog number

5432539

Companies
Manufacturer

GE Hangwei Medical Systems Co. Ltd.

WEST AREA OF BLDG. NO.3, NO.1 YONGCHANG NORTH ROAD, BEIJING, ECONOMIC & TECHNOLOGICAL DPVMT ZONE

Beijing

100176

CHINA