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Alerta De Seguridad para magnetic resonance equipment
Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por General Medical Merate Spa || GE Healthcare || GE Medical Systems Scs || GE Medical Systems Technologies Co Ltd || GE Medical Systems Information Technologies Gmbh || GE Medical Systems, Llc. || Xinaomdt Technology Co, Ltd || GEHangwei Medical Systems Co. Ltd || GE Medical Systems, Llc (Dba Ge Healthcare), || GE Healthcare Do Brasil Comércio E Servicos Para || Equipamentos Medico-Hospitalares Ltda || GE Healthcare (Tianjin) Company Limited.
¿Qué es esto?
Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.
Más información acerca de la data acá-
Tipo de evento
Safety alert
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ID del evento
I1609-396
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Número del evento
2007DM-0001028
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Fecha
2016-09-23
- País del evento
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Fuente del evento
INVIMA
- URL de la fuente del evento
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Notas / Alertas
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia. -
Notas adicionales en la data
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Causa
The manufacturer reports that if the output power of the rf amplifier is higher than the specific absorption rate (sar: specific absorption rate), the rf power monitor interrupts the acquisition, if the user performs a tps reset (treatment and storage of the transceiver) for the acquisition of a patient, the rf power monitor is turned off during the rest of the test for this patient, being unable to detect an abnormality of the higher rf transmission function, causing heating and localized doses higher than expected leading to may present potential serious adverse events to patients.
Device
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Modelo / Serial
SIGNA CREATOR and SIGNA EXPLORER
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Descripción del producto
It uses a diagnostic imaging technique that uses the magnetic properties of the atomic nuclei of the material (tissues, organs, bones, etc). This signal that reflects the atoms is captured and translated into very precise images, which reveal a number of normal and abnormal anatomical situations, that an experienced professional can interpret for the diagnosis of various pathologies.
- Manufacturer