Health product recall

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

  1. Aquilion ONE Vision
  2. 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