Events

Retiro De Equipo (Recall) de Vital Signs Monitor, Model 93300

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 Spacelabs Healthcare, Llc.

¿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
    56839
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3024-2011
  • Fecha de inicio del evento
    2010-09-23
  • Fecha de publicación del evento
    2011-08-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-08-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94612
  • 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
    Monitor, physiological, patient (with arrhythmia detection or alarms) - Product Code MHX
  • Causa
    The monitor has a 3 second delay in the waveforms and respiration alarm; the delay is not disclosed in the ifu.
  • Acción
    Spacelabs Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated September 24, 2010 to all affected customers. The letter describes the product, problem, and the action to be taken. The letter includes the revised Operator's Manual as a replacement for customers current manual. For Technical Support call Spacelabs Medical at 1-800-522-7025 and select 2.

Device

Vital Signs Monitor, Model 93300
  • Modelo / Serial
    Model 93300. Serial numbers: 3300-000001, 3300-000002, 3300-000003, 3300-000005, 3300-000006, 3300-000007, 3300-000008, 3300-000009, 3300-000010, 3300-000011, 3300-000012, 3300-000013, 3300-000014, 3300-000015, 3300-000016, 3300-000017, 3300-000018, 3300-000019, 3300-000020, 3300-000021, 3300-000022, 3300-000023, 3300-000024, 3300-000026, 3300-000027, 3300-000028, 3300-000029, 3300-000030, 3300-000031, 3300-000032, 3300-000033, 3300-000034, 3300-000035, 3300-000036, 3300-000037, 3300-000038, 3300-000039, 3300-000040, 3300-000041, 3300-000042, 3300-000043, 3300-000044, 3300-000045, 3300-000046, 3300-000047, 3300-000049, 3300-000050, 3300-000052, 3300-000053, 3300-000054, 3300-000055, 3300-000056, 3300-000057, 3300-000058, 3300-000059, 3300-000060, 3300-000061, 3300-000062, 3300-000063, 3300-000064, 3300-000065, 3300-000066, 3300-000067, 3300-000068, 3300-000069, 3300-000070, 3300-000071, 3300-000072, 3300-000073, 3300-000074, 3300-000075, 3300-000076, 3300-000077, 3300-000078, 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  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (Puerto Rico) and countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, FRANCE, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, KENYA, KOREA, REPUBLIC OF, KUWAIT, LEBANON, MACEDONIA, MALAYSIA, NEPAL, NETHERLANDS, NICARAGUA, OMAN, PALESTINE, PANAMA, PARAGUAY, PERU, PUERTO RICO, PHILIPPINES, QATAR, ROMANIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SRI LANKA, SWITZERLAND, SYRIAN ARAB REPUBLIC, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, and VIET NAM.
  • Descripción del producto
    Spacelabs Medical elance Vital Signs Monitor, Model 93300. || The Spacelabs elance Vital Signs Monitor and elance Central Station is a prescription device intended for use by healthcare professionals in all areas of a healthcare facility. It is indicated for use in adult and pediatric populations. The device facilitates the monitoring of: ECG with arrhythmia detection; respiration; non-invasive blood pressures; invasive blood pressures; body temperature; functional arterial oxygen saturation; and entidal CO2.
  • Manufacturer
    Spacelabs Healthcare, Llc

Manufacturer

Spacelabs Healthcare, Llc
  • Dirección del fabricante
    Spacelabs Healthcare, Llc, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Empresa matriz del fabricante (2017)
    OSI Systems Inc
  • Source
    USFDA