Events

Retiro De Equipo (Recall) de Device Recall Panoramic Xray Model PC1000

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 Panoramic Rental Corp..

¿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
    71653
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2538-2015
  • Fecha de inicio del evento
    2015-06-04
  • Fecha de publicación del evento
    2015-09-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-05-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138586
  • 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
    Unit, x-ray, extraoral with timer - Product Code EHD
  • Causa
    Jackscrew nut part failure potentially leading to device malfunction and patient/operator injury.
  • Acción
    The firm, Panoramic Corporation, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated 7/17/2015 via certified mail to customers on 7/20/2015, with response forms for customers to complete and return. The firm previously issued "IMPORTANT SERVICE BULLETIN" notices in 2003 and 2008 via FED-EX. The letter describes the product, problem and actions to be taken. The customers are instructed to select to use several options including replacing the failing part with one containing the safety feature, or trading in their machine for a newer one; discontinue using the devices immediately regardless the option you select, and complete and return the attached response card via email to recall@pancorp.com or fax to 260-489-5683. If the machine has been sold or donated to another dental outfit, the customer should notify Panoramic so that they can update their records. When the customer is reached, the firm will confirm whether or not the machine is still in service. Customers with questions may contact 800-654-2027 Monday through Thursday 8:00 AM to 6:00 PM and Friday 8:00 AM to 5:00 PM EST to discuss these options and determine which is best for their practice.

Device

Device Recall Panoramic Xray Model PC1000
  • Modelo / Serial
    Model Number: 800724-1, 800724-3; Serial Numbers 6001 to 13885, Manufactured Between 1996 and 2003
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: US (nationwide) all 50 states, including Puerto Rico; and countries of Antigua, Armenia, Aruba, Austria, Canada, China, Colombia, Ecuador, Egypt, England, France, Germany, Greece, Haiti, Honduras, Indonesia, Japan, Kenya, Lithuania, Mexico, Panama, Saudi Arabia, Singapore, Taiwan, Turkey, UAE, Uganda, Venezuela, Vietnam, and Virgin Islands.
  • Descripción del producto
    Panoramic X-ray Model PC-1000 || The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser 1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.
  • Manufacturer
    Panoramic Rental Corp.

Manufacturer

Panoramic Rental Corp.
  • Dirección del fabricante
    Panoramic Rental Corp., 4321 Goshen Rd, Fort Wayne IN 46818-1201
  • Empresa matriz del fabricante (2017)
    Young Innovations Inc.
  • Source
    USFDA