Events

Retiro De Equipo (Recall) de Device Recall DigitalDiagnost

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
    54641
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0847-2010
  • Fecha de inicio del evento
    2010-01-21
  • Fecha de publicación del evento
    2010-03-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-01-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88874
  • 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
    Solid State X-Ray Imager (Flat Panel/Digital Imager) - Product Code MQB
  • Causa
    Device failed to display appropriate labels indicating radiation symbol along with the required wording.
  • Acción
    Urgent - Field Safety Notice letters, dated January 20 & 21, 2010, were sent to customers. The letter identified the affected products, gave a description of the problem & the hazard involved, stated how to identify affected products, actions to be taken by the customer or user, and actions planned by the firm. Customers are to make sure that the relevant safety precautions are observed and check their operators console (EEC) if the labeling is present as shown in the drawing. If the labeling is missing, a Philips rep should be contacted. For further information or support concerning the issue, a Philips rep should be contacted at 800-722-9377.

Device

Device Recall DigitalDiagnost
  • Modelo / Serial
    Site Numbers:  102713, 102717, 102719, 504953, 505038, 541571, 545001, 545002, 41443853, 41443865, 41445819, 42380669, 42381462, 42456359, 42457219, 42495269, 42670799, 42670972, 42735547, 42800813, 42861810, 42868030, 43110437, 43136324, 43194952, 43249471, 43352116, 43352353, 43352366, 43352389, 43352789, 43453754, 43453757, 43622123, 43679113, 43680694, 43709240, 43718896, 43720045, 43721194, 43721661, 43902737, 43903999, 43985064, 44038310, 44067181, 44150484, 44229312, 44281712, 44291382, 44329875, 44428253, 44428523, 44428969, 44429963, 44429977, 44430170, 44430274, 44430275, 44430281, 44560894, 44562813, 44618188, 44640603, 44649438, 44650792, 44653666, 44654700, 44654760, 44671872, 44671873, 44891779, 44925674, 44945654, 45121894, 45142402, 45147685, 45168336, 45168583, 45168651, 45219739, 45312115, 45369771, 45369772, 45369773, 45404482, 45412925, 45414286, 45420726, 45427571, 45428681, 45441410, 45464313, 45485736, 45517411, 45543336, 45592706, 45593671, 45605694, 45631115, 47144505, 47180980, 47325696, 47401982, 47402790, 47403052, 47463075, 47552050, 47615224, 47616409, 47624694, 48433840, 48434300, 49001785, 49037133, 49311857,  and 49579551.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Devices were distributed through out the US in the following states: AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TX, UT, VA, WA, WI, and WY.
  • Descripción del producto
    DigitalDiagnost. General radiographic examinations and applications wherever a solid state X-ray imaging device can be used.
  • 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