Health product recall

RADREX-i (2018-09-12)

Starting date:
September 12, 2018
Posting date:
September 28, 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-67858

Affected products

RADREX-i

Reason

When the user performed radiography with wireless X-Ray Detector TFP-4336W, a message window was displayed on a monitor that said image transmission had not completed with no radiographic image. It also showed "ok" button to reacquire image data from the x-ray detector and "cancel" button to cancel the reacquisition. The user selected "ok" button, but the same message window appeared again. The user repeated the same operations several times and finally he/she selected "cancel" button to quit the re-acquisition mode. After system was restarted, the system worked normally.

Affected products

RADREX-i

Lot or serial number

W8B14X2014
W8B1512017
W8B1612027
W8B1612028
W8B1622029
W8B1622030
W8B1622031
W8B1632034
W8B1652039
W8C1832056

Model or catalog number

DRAD-3000E/W8

Companies
Manufacturer
Toshiba Medical Systems Corporation
1385 Shimoishigami
Otawara-Shi, Tochigi-ken
324-8550
JAPAN