Events

Retiro De Equipo (Recall) de Device Recall SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por GE Healthcare.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    70209
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1035-2015
  • Fecha de inicio del evento
    2015-01-07
  • Fecha de publicación del evento
    2015-02-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-09-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132519
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, nuclear magnetic resonance imaging - Product Code LNH
  • Causa
    At certain sites, the mru may not be connected to the magnet. in emergency situations, a disconnected mru could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries. the mru must be connected to the magnet at all times.
  • Acción
    GE Healthcare sent an "Urgent Medical Device Correction" letter GEHC Ref# 60876 dated January 6, 2015 to affected consignees. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers, & Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction & Contact Information. Customers were instructed to do the following: As a preventative measure, confirm that MRU is connected to the magnet by performing the following four step test on the MRU. 1. Verify the green CHARGER POWER LED is lit. 2. Depress and hold the TEST BATTERY switch for 15 seconds. The green BATTERY TEST LED should light and remain lit while the TEST BATTERY switch is depressed. 3. Place the TEST HEATER toggle switch in the A position. The green HEATER TEST LED should light. If it does not light, depress TEST HEATER LED switch to verify that the LED is functioning. 4. Place the TEST HEATER toggle switch in the B position. Green HEATER TEST LED should light. If it does not light, depress TEST HEATER LED switch to verify that the LED is functioning. If the MRU test does not perform as described in each of the 4 steps above, GEHC strongly recommends that you stop using the system, and immediately call your GEHC representative. Customers with questions may contact their local service representative. For questions regarding this recall call 1-800-437-1171.

Device

Device Recall SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
  • Modelo / Serial
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in all states in continental USA including DC, PR, GU, and the countries of ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BOLIVIA, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR,K ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GEORGIA, GERMANY, GREECE, GUADELOUPE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MALTA, MARTINIQUE, MAURITIUS, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE , UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, UZBEKISTAN, VENEZUELA, VIETNAM, ZAMBIA.
  • Descripción del producto
    This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, GE 1.5T Signa HDe, Optima MR360, Brivo MR355, Signa Excite-HD 1.5T & 3T, Signa Excite 1.5T HD Twinspeed, Signa Excite 1.5T HD Echospeed, Signa Excite 1.5T HD Highspeed, 1.5T Signa Infinity TwinSpeed , 1.5T Signa Infinity EchoSpeed Plus, 1.5T Signa Infinity HiSpeed Plus, 1.0T Signa Infinity HiSpeed Plus. 1.0T Signa Infinity SmartSpeed, Signa EXCITE 3.0T, Signa EXCITE 3.0T HD, Signa Excite 1.5T TwinSpeed, Signa Excite 1.5T EchoSpeed, Signa Excite 1.5T HiSpeed, Signa Excite 1.5T SmartSpeed, Signa Excite 1.5T, Signa Excite 3.0T, Signa Contour/I, Signa OpenSpeed, Vectra, MR Max, Optima MR450w GEM, Discovery MR750W GEM, Optima MR450w. || Product Usage: Magnetic resonance (MR) diagnostic devices are intended for producing images of the internal structures of the body based on the spatial distribution of molecules exhibiting magnetic resonance. Most MR systems are intended for diagnostic use.
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare
  • Dirección del fabricante
    GE Healthcare, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA