Events

Field Safety Notices about Apex, oxygenator for adults / Apex HP, oxygenator for adults / Avant, oxygenator for adults / Compactflo Evolution, oxygenator for adults / Eos, oxygenator for children and small adults / Eos ECMO, oxygenator for children and small adults / ECC.O, optimized for extracorporeal circulation / ECC.O 5, optimized for extracorporeal circulation / Primo2x, oxygenator for adults / Synergy oxygenator for adults / Synthesis, oxygenator for adults / Synthesis 4D, oxygenator for adults

According to Swedish Medical Products Agency, this field safety notices involved a device in Sweden that was produced by Sorin Group Italia.

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
Field Safety Notice
Event ID
444:2011/91437
Event Country
Sweden
Event Source
SMPA
Event Source URL
https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2012/Hjart-lungmaskinsystem--Oxygenatorer--Sorin-Group-Italia/#
Notes / Alerts

Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 Sweden.
Extra notes in the data

FSCA002-11
Action
Warning information. New instructions. Modification of instructions.

Device

Apex, oxygenator for adults / Apex HP, oxygenator for adults / Avant, oxygenator for adults / Com...

Model / Serial
Product Description
Heart-lung machine
Manufacturer
Sorin Group Italia

Manufacturer

Sorin Group Italia

Manufacturer Parent Company (2017)
LivaNova PLC
Source
SMPA

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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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