Events

Field Safety Notices about Twin speed 1.5T Infinity system Infinity Signa MR systems with excitation technology, 3.0T Signa Twin speed Infinity with Excite, Excite 1.5T Signa, Signa Excite 3.0T, 1.5T Signa HDx, 3.0T Signa HDx, Signa 1.5T and HDxt 3.0T, 3.0T Signa with Excite, 1.0T and 1.5T Signa Horizon LX, Signa Horizon, Signa Advantage SP, 0.7T Signa Open Speed, HDE Signa 1.5T, Optima MR360 and MR355 Brivo MR systems

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

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
444:2010/85162
Event Country
Sweden
Event Source
SMPA
Event Source URL
https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2011/Rontgenutrustning---MR-gradientkablar--GE-Healthcare/#
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

FMI 60789 – 67813 - 67903
Action
Control of products. Modification of products.

Device

Twin speed 1.5T Infinity system Infinity Signa MR systems with excitation technology, 3.0T Signa ...

Model / Serial
Product Description
X-ray equipment
Manufacturer
GE Healthcare

Manufacturer

GE Healthcare

Manufacturer Parent Company (2017)
General Electric Company
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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