Events

Recall of (1) Ultrasonic diagnostic device Aplio i900 TUS - AI 900 (2) Ultrasonic diagnostic device Aplio i 800 TUS - AI 800 (3) Ultrasonic diagnostic device Aplio i 700 TUS - AI 700 (4) Ultrasonic diagnostic device APLIO 500 TUS - A 500 ) Ultrasonic diagnostic device APLIO 400 TUS-A 400 (6) Ultrasound diagnostic device APLIO 300 TUS-A 300 (7) Ultrasound diagnostic device XARIO 200 TUS-X 200 (8) Ultrasonic diagnostic device XARIO 200 TUS- X 200 S Sonic diagnostic equipment XARIO 100 TUS - X 100 (10) Ultrasound workstation package UltraExtend FX TUW - U 001

According to Pharmaceuticals and Medical Devices Agency, Japan, this recall involved a device in Japan that was produced by Toshiba Medical Systems Co., Ltd..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here

Type of Event
Recall
Event ID
2-7448
Date
2017-05-11
Event Country
Japan
Event Source
PMDAJ
Event Source URL
http://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-7448
Notes / Alerts

Japanese data is current through August 2018. All of the data comes from the Japanese Pharmaceuticals and Medical Devices Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Japan.
Extra notes in the data

Recovery end

Device

(1) Ultrasonic diagnostic device Aplio i900 TUS - AI 900 (2) Ultrasonic diagnostic device Aplio i...

Model / Serial
Product Description
(1) - (9) General purpose ultrasound diagnostic imaging equipment (10) Ultrasound equipment workstation
Manufacturer
Toshiba Medical Systems Co., Ltd.

Manufacturer

Toshiba Medical Systems Co., Ltd.

Manufacturer Parent Company (2017)
Canon Inc
Source
PMDAJ

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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