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Diagnostic and High Voltage X-Ray Generator (2016-11-25)
- Starting date:
- November 25, 2016
- Posting date:
- December 13, 2016
- 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-61420
Affected Products
- Diagnostic X-Ray Generator
- X-Ray High Voltage Generator
Reason
It has been found that the x-ray generator of the system could possibly terminate the exposure prematurely during an examination. X-ray generation was stopped in a very short time (about 1 millisecond) in radiography. After the system was rebooted, system operation returned to normal.
Affected products
A. Diagnostic X-Ray Generator
Lot or serial number
- J1G0653183
- J1H0713302
- J1H0933456
Model or catalog number
- KXO-80XM
- KXO-80XM/J1
Companies
- Manufacturer
-
Toshiba Medical Systems Corporation
1385 Shimoishigami
OTAWARA-SHI, TOCHIGI-KEN
324-8550
JAPAN
B. X-Ray High Voltage Generator
Lot or serial number
99A0542035X
99C1192362
Model or catalog number
KXO-80XD
Companies
- Manufacturer
-
Toshiba Medical Systems Corporation
1385 Shimoishigami
OTAWARA-SHI, TOCHIGI-KEN
324-8550
JAPAN