Events

Retiro De Equipo (Recall) de Device Recall Motorized Height Ceiling Suspensions (MCS) for CV Xray systems

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 Medical Systems North America Co. Phillips.

¿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
    48992
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2210-2010
  • Fecha de inicio del evento
    2008-06-26
  • Fecha de publicación del evento
    2010-08-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-12-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72469
  • 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
    Motorized Height Ceiling Suspension - Product Code IZI
  • Causa
    Monitor ceiling carriage may separate from the monitor ceiling suspension.
  • Acción
    On 07/02/08, the firm sent a "Urgent - Device Correction" letter to all their consignees. The letter describes a product as X-Ray system with Monitor Ceiling Suspension and motorized height movement. The consignees are informed that the fixation bolts supporting the monitor ceiling carriage may come loose creating a situation which may allow the monitor ceiling carriage to separate from motorized height Monitor Ceiling Suspension and that would cause serious injury to patient and user. The firm has issued a mandatory Field Correction Action to correct the problem and the firm's technicians will inspect all ceiling suspension actuators for loose screws. If loose screws are found the actuator will be replaced. Consignees should call Philips Call Center at 800-722-9377 #5, #4, #1, and Reference FCO72200126.

Device

Device Recall Motorized Height Ceiling Suspensions (MCS) for CV Xray systems
  • Modelo / Serial
    Products are identified as Equipment numbers:  13046, 25934, 34702, 38592, 41455, 44791, 45059, 52463, 62671, 82824, 83667, 85095, 85137, 85190, 85195, 86189, 86341, 86575, 86914, 86981, 87359, 87364, 100788, 101036, 101077, 101612, 101952, 102664, 103147, 103238, 103265, 103270, 103281, 103283, 103380, 103525, 103526, 103562, 103564, 103781, 103891, 104075, 104076, 104077, 104149, 104464, 104497, 104670, 104950, 104952, 104953, 104954, 104955, 104956, 104957, 104958, 104959, 105073, 105139, 105140, 105304, 105489, 105598, 105670, 105674, 105779, 105953, 105960, 203880, 215045, 215140, 500038, 504493, 504655, 504666, 504674, 504733, 504742, 504747, 504776, 504779, 505064, 505077, 505111, 505111, 505252, 505271, 505281, 505363, 505421, 505486, 505530, 505538, 505650, 505809, 505858, 505860, 505861, 505876, 505968, 506026, 506049, 506069, 506119, 506169, 506469, 506509, 506538, 506539, 506540, 506541, 506564, 506616, 506621, 506637, 506778, 519115, 519118, 519136, 519195, 519196, 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  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    United States and Canada.
  • Descripción del producto
    Motorized Height Ceiling Suspensions (MCS) and motorized height movement (actuator) for X-ray systems. || Usage: Ceiling suspension unit with an actuator to hold monitors and X-ray shields.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

Philips Medical Systems North America Co. Phillips
  • Dirección del fabricante
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA