The Implant Files -
International Medical Devices Database
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translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice
According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by Visionsense Ltd.
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.
Learn more about the data here-
Type of Event
Recall / Field Safety Notice
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Event ID
mdprc 060 06 11 000
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Event Initiated Date
2011-06-18
- Event Country
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Event Source
SFDA
- Event Source URL
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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: NCAR
SFDA urges all hospitals that have devices subjected to recall, to contact the company. -
Reason
May have an improperly sealed metal and glass window in the tip of the scope and possibly a mis-assembled camera head positioned behind the window. this combination of factors may lead to the metal and glass window becoming dislodged from the scope tip during cleaning and render the unit inoperable. the metal and glass window may also become dislodged during use therefore may represent a potential health hazard.
Device
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Model / Serial
VSII Laparoscope Integrated 0 Deg Camera. 30 Degree cameras are fit for use and are not affected by this recall.
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Product Description
Cameras, Video, Endoscopic
- Manufacturer
Manufacturer
- Manufacturer Parent Company (2017)
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Source
SFDA