Aquilion ONE Vision, Aquilion PRIME (2019-02-19)
- Starting date:
- February 19, 2019
- Posting date:
- March 8, 2019
- 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-69246
Affected Products
- Aquilion ONE Vision
- Aquilion PRIME
Reason
In the applicable systems, scanning may be interrupted due to an error during execution of an exam plan and the system cannot be shut down normally. As a result, it is necessary to forcibly shut down the system and reboot it using the power switch, resulting in loss of the acquired raw data.
Affected products
A. Aquilion ONE Vision
Lot or serial number
- 6KA1612087
- 7KA1622052
- 7KA1772073
- 7NA1632055
Model or catalog number
TSX-301C
Companies
- Manufacturer
-
Canon Medical Systems Corporation
1385 Shimoishigami
Otawara-shi, Tochigi
324-8550
JAPAN
B. Aquilion PRIME
Lot or serial number
- BSA1662297
- BSA1672308
- BSA1712371
- MQC1892058
- MQC1892060
- MSC1882057
- MSC1892059
Model or catalog number
TSX-303A
Companies
- Manufacturer
-
Canon Medical Systems Corporation
1385 Shimoishigami
Otawara-shi, Tochigi
324-8550
JAPAN