Health product recall

Optima CT660 and Revolution EVO (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-67274

Affected products

A. Optima CT660
B. Revolution EVO

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

A. Optima CT660

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

5454001-X

Companies
Manufacturer

GE Healthcare Japan Corporation

7-127, Asahigaoka, 4-Chome, Hino-Shi

Tokyo

191-8503

JAPAN

B. Revolution EVO

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

5454001-160
5454001-260
5454001-60
5454001-61

Companies
Manufacturer

GE Healthcare Japan Corporation

7-127, Asahigaoka, 4-Chome, Hino-Shi

Tokyo

191-8503

JAPAN