International Medical Devices Database

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

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Type of Event
Safety alert
Date
2011-09-14
Event Country
Hong Kong
Event Source
DH
Event Source URL
https://www.mdco.gov.hk/english/safety/recalls/recalls_20110914.html
Notes / Alerts

Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Extra notes in the data

Medical Device Safety Alert
Reason
Voluntary recall notification: cochlear nucleus ci500 cochlear implant range cochlear limited has issued a voluntary recall notification regarding cochlear nucleus ci500 cochlear implant range. the range includes nucleus ci512 implant; nucleus ci513 implant, nucleus ci551 double array implant and nucleus abi 541 auditory brainstem implant. according to cochlear, the affected product has been distributed in hong kong. cochlear will directly contact each of the healthcare professionals to make arrangements for the return of the devices. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Nucleus CI500 cochlear implant range

Model / Serial
Product Description
Medical Device Safety Alert: Cochlear Nucleus CI500 cochlear implant range
Manufacturer
Cochlear Limited

Manufacturer

Cochlear Limited

Manufacturer Parent Company (2017)
Cochlear Ltd.
Source
DH

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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Safety Alert for Nucleus CI500 cochlear implant range

What is this?

Device

Nucleus CI500 cochlear implant range

Manufacturer

Cochlear Limited