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Aquilion Systems (2013-09-09)
- Starting date:
- September 9, 2013
- Posting date:
- October 16, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-36207
Recalled Products
A. Aquilion 64 System
B. Aquilion One System - Main Unit
C. Aquilion Prime - Main Unit
D. Aquilion TSX-101A_/Q - Main Unit
Reason
In some Aquilion One and Aquilion Prime CT scanners with certain software version, due to a problem of the X-Ray output control software, the X-Ray output conditions cannot be set correctly in some cases. As a result, occasionally the X-Ray exposure under the scan conditions used for contrast study may not start.
Affected products
A. Aquilion 64 System
Lot or serial number
Serial numbers:
- HCB1023751
- HCB1023752
- HCB1083820
- HCB1083821
- HCB10X3839
- HCB1163909
Model or catalog number
- TSX-101A/HX
Companies
- Manufacturer
-
Toshiba Medical Systems Corp.
1385 Shimoishigami, Otawara-Shi
Tochigi-Ken
324-8550
JAPAN
B. Aquilion One System - Main Unit
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- TSX-301A_/2C
Companies
- Manufacturer
-
Toshiba Medical Systems Corp.
1385 Shimoishigami, Otawara-Shi
Tochigi-Ken
324-8550
JAPAN
C. Aquilion Prime - Main Unit
Lot or serial number
Serial numbers:
- 1QA11X2071
- 1SB1282153
- 1SB12X2159
Model or catalog number
- TSX-302A
Companies
- Manufacturer
-
Toshiba Medical Systems Corp.
1385 Shimoishigami, Otawara-Shi
Tochigi-Ken
324-8550
JAPAN
D. Aquilion TSX-101A_/Q - Main Unit
Lot or serial number
Serial number:
- QQA12Z2224
Model or catalog number
- TSX-101A_/QQ
Companies
- Manufacturer
-
Toshiba Medical Systems Corp.
1385 Shimoishigami, Otawara-Shi
Tochigi-Ken
324-8550
JAPAN