Events

Retiro De Equipo (Recall) de Device Recall Philips Healthcare 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 Philips Healthcare Inc..

¿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
    61926
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1818-2012
  • Fecha de inicio del evento
    2012-05-22
  • Fecha de publicación del evento
    2012-06-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-02-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109499
  • 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
    Peripheral electromagnetic field (pemf) to aid wound healing - Product Code MQB
  • Causa
    With digital diagnost (didi) r 2.0.2 a mirrored "r in a circle" is burnt into the image (if mirrored) in the lower right corner of the image. when such an image is mirrored back inside the pacs system, an unmirrored "r in a circle" appears in the lower left corner. this can be mistaken for a "right patient side" marker, although this can appear on the left patient side.
  • Acción
    Philips Healthcare issued a Field Safety Notice on 5/22/12 advising users of the error. A software update (Rel 2.1.2) will issue to correct the problem. Contact your local Philips representative. 1-800-722-9377. For questions regarding this recall call 978-687-1501.

Device

Device Recall Philips Healthcare Imaging
  • Modelo / Serial
    Software release 2.0.2 and 2.0.2SP1 including mirror icon
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of: Nationwide Foreign: Canada AFGHANISTAN ALBANIA ALGERIA ANGOLA ARGENTINA ARMENIA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHAMAS BAHRAIN BANGLADESH BARBADOS BELARUS BELGIUM BENIN BHUTAN BOLIVIA BOSNIA&HERZEGOVINA; BRAZIL BRUNEI DARUSSALAM BULGARIA BURUNDI CAMBODIA CAMEROON CANARY ISLANDS CHAD CHILE CHINA COLOMBIA CONGO CONGO,DEMOCRATIC COSTA RICA COTE D'IVOIRE CROATIA CUBA CYPRUS CZECH REPUBLIC DENMARK DJIBOUTI DOMINICAN REPUBLIC ECUADOR EGYPT EL SALVADOR EQUATORIAL GUINEA ERITREA ESTONIA ETHIOPIA fake test ssd FINLAND FRANCE FRENCH GUIANA GABON GAMBIA GEORGIE GERMANY GHANA GREECE GUADELOUPE GUAM GUATEMALA GUINEA GUYANA HONDURAS HONG KONG HUNGARY ICELAND INDIA INDONESIA IRAN IRAQ IRELAND ISRAEL ITALY JAMAICA JAPAN JORDAN KAZAKSTAN KENYA KUWAIT KYRGYZSTAN LAO PEOPLE'S DEM.REP LATVIA LEBANON LIBERIA LIBYAN ARAB JAMAHIRI LIECHTENSTEIN LITHUANIA LUXEMBOURG MACAU MACEDONIA MALAWI MALAYSIA MALI MALTA MARTINIQUE MAURITANIA MAURITIUS METRACOM MEXICO MOLDOVA MONGOLIA MOROCCO MOZAMBIQUE NAMIBIA NEPAL NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA NIGERIA NORTH KOREA NORWAY OMAN PAKISTAN PALESTINE PANAMA PARAGUAY PERU PHC BEST PHILIPPINES PMCC BU Canada PMCC BU USA POLAND PORTUGAL PUERTO RICO QATAR REUNION ROMANIA RUSSIA RWANDA SAUDI ARABIA SENEGAL SERBIA&MONTE; NEGRO SIERRA LEONE SINGAPORE SLOVAKIA SLOVENIA SOMALIA SOUTH AFRICA SOUTH KOREA SPAIN SRI LANKA SUDAN SURINAME SWEDEN SWITZERLAND SYRIAN ARAB REPUBLIC TAIWAN TAJIKISTAN TANZANIA THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY TURKMENISTAN UGANDA UKRAINE Unidentified Country UNITED ARAB EMIRATES UNITED KINGDOM URUGUAY UZBEKISTAN VENEZUELA VIET NAM YEMEN ZAMBIA ZIMBABWE
  • Descripción del producto
    Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon || Stationary Fluoroscopic system
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • Dirección del fabricante
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA