Events

Retiro De Equipo (Recall) de Device Recall Panorama HFO

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
    57561
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1458-2011
  • Fecha de inicio del evento
    2010-02-05
  • Fecha de publicación del evento
    2011-03-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-08-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96629
  • 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
    System, nuclear magnetic resonance imaging - Product Code LNH
  • Causa
    In the examcard mobiflex the patient position is "prone" which must be "supine". the result is mislabeling of left and right side of the patient. if this is not detected by the operator there is a risk of wrong treatment or the need of additional x-ray during treatment.
  • Acción
    Philips began sendng out the URGENT-Device Correction Notice letter dated February 5, 2010, ro all affected consignees on February 10, 2010. The consignees were advised to change the patient position from "Prone" immediately to "Supine" and store the corrected ExamCard in the hospital database if they use the ExamCard, MobiFlex dual Injection. Consignees were instructed to call Philips Healthcare Call Center at 800-722-9377 #5 (then follow prompts) and also reference "FCO 78100318" with any communication.

Device

Device Recall Panorama HFO
  • Modelo / Serial
    Site Numbers: 533860, 533900, 535230, 535664, 538574, 539374, 540482, 541065, 541851, 542236, 544039, 544148, 544696, 545034, 545732, 545981, 546206, 547843, 547897, 548040, 548064, 549389, 549909, 550324, 550439, 551025, 551583, 552453, 552526, 552609, 553116, 554715, 556146, 556161, 556895, 557599, 41443708, 41444456, 41444458, 41444745, 41445015, 41445018, 41445530, 41445594, 41445595, 41446119, 41455905, 41455908, 41455913, 41455915, 41455923, 41455938, 41455940, 41455954, 42047935, 42057444, 42293607, 42392891, 42608348, 42850814, 42892497, 42917294, 43708886, 44062048, 44247559, 44605983, 45130117, 45245963, 45246494, 45246504, 45445404, 47157157, 47230785, 47455618, 47480028, 47848863, 49060365, 49060404, 49416204, 49424702, 49776644,  and 49861074.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including the following states: AL, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, NE, NH, NJ, NY, OH, OR, SC, TN, TX, VA, VT, WI, and WV.AL, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, NE, NH, NJ, NY, OH, OR, SC, TN, TX, VA, VT, WI, and WV. There was no foreign consignees.
  • Descripción del producto
    The Panorama HFO system has the Traceable Item Identification (12NC): || 9896 030 17741-SW R 2.5.1 (shipped as R 2.5.1, upgraded to R 2.5.3 via FCO). || 9896 030 19641-SW R 2.5.3 || 9896 030 19861-SW R 2.6.1 || 9896 030 19862-SW R 2.6.1 || 9896 030 19863-SW R 2.6.3
  • 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