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Aquilion Systems (2013-09-09)

Report a Concern
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