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Aquilion One System (2015-06-11)
- Starting date:
- June 11, 2015
- Posting date:
- July 9, 2015
- 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-54170
Recalled Product
- AQUILION ONE SYSTEM - MAIN UNIT
- AQUILION ONE SYSTEM (TSX-301C) - MAIN UNIT
- AQUILION PRIME MULTISLICE HELICAL CT SCANNER
Reason
It has been found that in a contrast study with Multi-phase Helical scanning, if specific operations are performed, the acquired raw data may not be saved.
Affected products
A.AQUILION ONE SYSTEM - MAIN UNIT
Lot or serial number
>10 NUMBERS, CONTACT MFG
Model or catalog number
- TSX-301A_/2C
- TSX-301A_/2K
Companies
- Manufacturer
-
Toshiba Medical Systems Corporation
1385 Shimoishigami
OTAWARA-SHI
324-8550
JAPAN
B.AQUILION ONE SYSTEM (TSX-301C) - MAIN UNIT
Lot or serial number
>10 NUMBERS, CONTACT MFG
Model or catalog number
- TSX-301C_/1C
- TSX-301C_/1K
- TSX-301C_/3K
Companies
- Manufacturer
-
Toshiba Medical Systems Corporation
1385 Shimoishigami
OTAWARA-SHI
324-8550
JAPAN
C.AQUILION PRIME MULTISLICE HELICAL CT SCANNER
Lot or serial number
>10 NUMBERS, CONTACT MFG
Model or catalog number
- TSX-303A_2Q
- TSX-303A_2R
- TSX-303A_2S
- TSX-303A_2T
Companies
- Manufacturer
-
Toshiba Medical Systems Corporation
1385 Shimoishigami
OTAWARA-SHI
324-8550
JAPAN