Events

Retiro De Equipo (Recall) de Device Recall Vital Sign elance 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
    59441
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2916-2011
  • Fecha de inicio del evento
    2011-07-06
  • Fecha de publicación del evento
    2011-08-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-01-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102807
  • 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
    Patient Physiological Monitor (with arrhythmia detection or alarms) - Product Code MHX
  • Causa
    Model 93300 vital signs monitor may stop operating while in use, and when this occurs, the monitor may also fail to power on. the resulting situation may cause a loss of monitoring for the patient.
  • Acción
    Spacelabs Healthcare, Llc sent an "Urgent-Medical Device Correction" letter dated 18 July 2011 to all affected customers. The letter notified the customers of the problem and recommended customers make their staff aware. It also informed them a Field Service Engineer will contact them to check, and if necessary make adjustments. Customers can contact Spacelabs Healthcare at 800-522-7025 and select 2 for Technical Support or outside the U.S. at +86512-8717-1888, extension 304.

Device

Device Recall Vital Sign elance Monitor, Model 93300
  • Modelo / Serial
    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, 3300-000079, 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  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: (USA) Nationwide distribution including the state of WI, and the countries of Puerto Rico, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Chile, China, Colombia, Cyprus, Dominican Republic, Ecuador, Egypt, El Salvador, France, Germany, Greece, Guatemala, Honduras, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Kenya, Korea, Kuwait, Lebanon, Malaysia, Napel, Netherlands, Nicaragua, Oman, Palestine, Panama, Paraguay, Peru, Philippines, Republic of Macedonia, Romania, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Syrian Arab Republic, Thailand, Trinidad and Tobago, Tunisia, Turkey, UAE, United Kingdom, Venezuela, and Vietnam.
  • Descripción del producto
    Vital Sign elance Monitor, Model 93300 || Spacelabs Healthcare, Llc. || A vital signs patient monitor with arrhythmia detection.
  • 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