This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Aplio 500, 300, I700, I800 Main Units (2017-05-16)
- Starting date:
- May 16, 2017
- Posting date:
- June 7, 2017
- 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-63540
Affected Products
A. Aplio 500 - Main Unit
B. Aplio 300 - Main Unit
C. Aplio-I700 - Main Unit
D. Aplio-I800 - Main Unit
Reason
When continuous trace is used as the tracing method for velocity trace measurement, the displayed mean pressure gradient (MPG) value may be as low as half that obtained by spline tracing in the diagnostic ultrasound system.
Affected products
A. Aplio 500 - Main Unit
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
TUS-A500
Companies
- Manufacturer
-
Toshiba Medical Systems Corporation
1385 Shimoishigami
OTAWARA-SHI, TOCHIGI-KEN
324-8550
JAPAN
B. Aplio 300 - Main Unit
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
TUS-A300
Companies
- Manufacturer
-
Toshiba Medical Systems Corporation
1385 Shimoishigami
OTAWARA-SHI, TOCHIGI-KEN
324-8550
JAPAN
C. Aplio-I700 - Main Unit
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
TUS-AI700
Companies
- Manufacturer
-
Toshiba Medical Systems Corporation
1385 Shimoishigami
OTAWARA-SHI, TOCHIGI-KEN
324-8550
JAPAN
D. Aplio-I800 - Main Unit
Lot or serial number
More than10 numbers, contact manufacturer
Model or catalog number
TUS-AI800
Companies
- Manufacturer
-
Toshiba Medical Systems Corporation
1385 Shimoishigami
OTAWARA-SHI, TOCHIGI-KEN
324-8550
JAPAN