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
14856
Event Initiated Date
2013-06-19
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
Following an incident at a medical centre in the united states a patient died due to injuries sustained while being scanned on an infinia hawkeye 4 system. the cause of the incident is under investigation. users are recommended to ensure;, 1/ only qualified service personnel maintain the equipment, 2/ that preventative maintenance procedures are conducted according to the documented schedule, 3/ all users re-review the safety chapter sections of the system manual.
Action
Manufacturer to issue advice regarding use

Device

GE Infinia Nuclear Medicine Systems

Model / Serial
Model: All Infinia systems manfactured from 2003 to 2013; all VG and VG Hawkeye systems manufactured from 1996 to 2003; all Helix systems manfactured from 1992 to 1996, Affected:
Product Classification
Radiology Devices
Manufacturer
GE Medical Systems Functional Imaging Haifa

Manufacturer

GE Medical Systems Functional Imaging Haifa

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 Infinia Nuclear Medicine Systems

What is this?

Device

GE Infinia Nuclear Medicine Systems

Manufacturer

GE Medical Systems Functional Imaging Haifa