International Medical Devices Database

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

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Type of Event
Recall / Field Safety Notice
Event ID
mdprc 141 03 16 000
Event Initiated Date
2016-03-17
Event Country
Saudi Arabia
Event Source
SFDA
Event Source URL
https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=9065
Notes / Alerts

Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
Extra notes in the data

Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Reason
The vacuum suction tubing could be kinked within the machine resulting in suction less than the 20 lpm required by iso 10079-3. if this issue is left unresolved, it could result in inadequate suction performance to clear the airway and inadequate ventilation of the patient.

Device

Aisys family of Anesthesia devices .

Model / Serial
Specific Aisys family of Anesthesia devices with serial numbers as identified in the appendix.
Product Description
Anesthesia device
Manufacturer
GE Healthcare

Manufacturer

GE Healthcare

Manufacturer Parent Company (2017)
General Electric Company
Manufacturers representative
GE Healthcare
Source
SFDA

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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What is this?

Device

Aisys family of Anesthesia devices .

Manufacturer

GE Healthcare