Events

Recall of (5) Hitachi MR Imaging Equipment AIRIS Soleil (6) Hitachi MR Imaging System AIRIS Elite (2) Hitachi MR Imaging System AIRIS Light (3) Hitachi MR Imaging System AIRIS Vento LT ) Hitachi MR Imaging System AIRIS Mate (7) Hitachi MR Imaging System AIRIS Vento (8) Hitachi MR Imaging System APERTO Lucent (9) Hitachi MR Imaging System Aperto Eterna (10) Hitachi MR Imaging System Aperto Series (11) Hitachi MR Imaging System ECHELON OVAL (12) Hitachi MR Imaging Equipment ECHELON RX (13) Hitachi MR Imaging Equipment Echelon Vega (14) Hitachi MR Imaging System TRILLIUM OVA

According to Pharmaceuticals and Medical Devices Agency, Japan, this recall involved a device in Japan that was produced by Hitachi, 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
3-2421
Date
2017-09-19
Event Country
Japan
Event Source
PMDAJ
Event Source URL
http://www.info.pmda.go.jp/rgo/MainServlet?recallno=3-2421
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

2. September 29, 2017 Correction of "2. Target lot, quantity and shipping time"

Device

(5) Hitachi MR Imaging Equipment AIRIS Soleil (6) Hitachi MR Imaging System AIRIS Elite (2) Hitac...

Model / Serial
Product Description
(1) - (10) Permanent magnet type whole body MR device (11) - (14) Superconducting magnet type whole body MR device
Manufacturer
Hitachi, Ltd.

Manufacturer

Hitachi, Ltd.

Manufacturer Parent Company (2017)
Hitachi Ltd
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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