International Medical Devices Database

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
15343
Event Initiated Date
2013-09-09
Event Country
New Zealand
Event Source
NZMMDSA
Event Source URL
https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
Notes / Alerts

Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Extra notes in the data

Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
Reason
As a result of a manufacturing issue, the buttons on the left, right, and bottom keypads may not always detect button presses. this may result in the inability to access certain menu functions which could possibly lead to delay in treatment.
Action
Product to be modified

Device

GE Engstrom Ventilator, Aespire View, Aisys, & Avance Anaesthesia Work Stations

Model / Serial
Model: Engstrom Ventilator, Aespire View, Aisys, & Avance, Affected: Manufactured between 23-Apr-2013 and 22-Jul-2013
Product Classification
Anesthesiology Devices
Manufacturer
Datex-Ohmeda Inc

Manufacturer

Datex-Ohmeda Inc

Manufacturer Parent Company (2017)
General Electric Company
Source
NZMMDSA

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

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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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The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

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Recall of GE Engstrom Ventilator, Aespire View, Aisys, & Avance Anaesthesia Work Stations

What is this?

Device

GE Engstrom Ventilator, Aespire View, Aisys, & Avance Anaesthesia Work Stations

Manufacturer

Datex-Ohmeda Inc