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AQUILION ONE SYSTEM (2015-01-06)
- Starting date:
- January 6, 2015
- Posting date:
- April 13, 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-52847
Recalled Products
- AQUILION ONE SYSTEM - MAIN UNIT
- AQUILION ONE SYSTEM (TSX-301C) - MAIN UNIT
Reason
During biopsy procedure, patient was scanned with routine helical protocol. Although the image was acquired, no real-time image was displayed.
Affected products
A. AQUILION ONE SYSTEM - MAIN UNIT
Lot or serial number
- 2CA0852030
- 2CA0872039
- 2CA0912100
- 2CA0972125
- 2CA09Y2156
- 2CA1062201
- 2KC1172339
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
- 1CB12Y2020
- 1KC13Z2091
- 1KC1442095
- 1KD1412093
Model or catalog number
- TSX-301C_/1C
- TSX-301C_/1K
Companies
- Manufacturer
-
Toshiba Medical Systems Corporation
1385 Shimoishigami
OTAWARA-SHI
324-8550
JAPAN