Events

Retiro De Equipo (Recall) de Device Recall Pelton & Crane

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 Pelton & Crane Company.

¿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
    61262
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1177-2012
  • Fecha de inicio del evento
    2012-02-20
  • Fecha de publicación del evento
    2012-03-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107682
  • 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, operative dental - Product Code EIA
  • Causa
    Modification of the pelton & crane spirit 3000 unit disabled the tlc safedrive feature rendering it ineffective in detecting whether the handpiece is potentially damaged or heating up.
  • Acción
    Pelton & Crane sent an Urgent Medical Device Recall letter dated February 20, 2012 to all affected customers. The letter identifies the affected product, problem and actions to be taken. The letter states that a Pelton & Crane representative will be contacting the customers to schedule a service appointment with the end user of the device so that the affected TLC SAFEdrive circuit board can be replaced and returned to Pelton & Crane. Customers were instructed to complete the attached Recall Acknowledgement/Return Form and fax it to Pelton & Crane, attention Frank Ray, at (704) 587-7250. The letter also requested customers to mail the original Recall Acknowledgement/Return Form in the enclosed self addressed stamped envelope.

Device

Device Recall Pelton & Crane
  • Modelo / Serial
    Model #SET30, Catalog #3120, Serial numbers 4096 and 4099.
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    (USA) Nationwide Distribution
  • Descripción del producto
    Pelton & Crane Spirit 3000 dental operative unit with the TLC SAFEdrive option, 1727 Fuehauf Dr. Charlotte, NC 28273 || Product Usage: || The intended use of the dental operative unit is for supplying power and to serve as a base for other dental devices, such as a dental hand piece, air/water syringe, oral cavity evacuator, a suction operative unit, and other dental devices. The TLC SAFEdrive option is an optional feature that monitors the operation of the high speed hand piece and gives an audible and visual signal to let the user know if the hand piece is potentially damaged or heating up.
  • Manufacturer
    Pelton & Crane Company

Manufacturer

Pelton & Crane Company
  • Dirección del fabricante
    Pelton & Crane Company, 11727 Fruehauf Dr, Charlotte NC 28273
  • Empresa matriz del fabricante (2017)
    Pelton & Crane Company
  • Source
    USFDA