Events

Retiro De Equipo (Recall) de Device Recall Helios

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 / Marus / DCI Equipment / KaVo.

¿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
    73460
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1268-2016
  • Fecha de inicio del evento
    2016-03-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-06-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144228
  • 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
    Light, operating, dental - Product Code EAZ
  • Causa
    The firm received two customer complaints local pelton & crane distributors that the helios 3000 track mounted dental lights were missing the two 8/32x3/16 set screws during the initial installation of the dental light.
  • Acción
    Pelton & Crane sent an Urgent Medical Device Recall letters to affected customers on March 8, 2016 and will be completed by 3/11/2016. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the Field Correction Acknowledgement Form in the enclosed self-address stamped envelope to Pelton & Crane. For questions or concerns regarding this recall please call 1-800-659-6560, ext. 7227.

Device

Device Recall Helios
  • Modelo / Serial
    Model/Serial No. - HLT-5535, 5543, 5536, 5537, 5538, 5556, 5540, 5541, 5545, 5546, 5515, 5500, 5503, 5520, 5521, 5547, 5548, 5549, 5550, 5551, 5552, 5510, 5558, 5522, 5523, 5524, 5525, 5526, 5527, 5528, 5529, 5530, 5531, 5532, 5501, 5502, 5504, 5505, 5534, 5508, 5509, 5533, 5516, 5517, 5518, 5519, 5544, 5553, 5554, 5555, 5542, 5557, 5506, 5507, 5511, 5498, 5539, 5499, 5512, 5513, 5514; Model/Serial No. HL3T-11110, 11102, 11103, 11104, 11105, 11106, 11099, 11164, 11165, 11166, 11167, 11193, 11170, 11171, 11118, 11119, 11120, 11145, 11146, 11147, 11148, 11149, 11121, 11123, 11150, 11113, 11114, 11115, 11116, 11117, 11168, 11169, 11158, 11187, 11133, 11144, 11136, 11137, 11138, 11139, 11140, 11141, 11142, 11143, 11177, 11111, 11112, 11135, 11190, 11191, 11192, 11100, 11182, 11183, 11185, 11186, 11134, 11122, 11124, 11125. 11126, 11127, 11128, 11129, 11130, 11131, 11132, 11155, 11156, 11157, 11159, 11160, 11161, 11107, 11108, 11176, 11172, 11173, 11174, 11175, 11109. 11151, 11152, 11153, 11154, 11101, 11181, 11184, 11188, 11189, 11178, 11179, 11180, 11162, 11163
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the states of AZ, AR, CA, CO, CT, FL, IA, ID, IL, IN, MA, MI, MN, NJ, NY, NC, OH, OR, PA, TN, TX, UT, VA, WI and Canada
  • Descripción del producto
    Helios HL3T and HLT Track Mounted Dental Lights || Product Usage: || The product is intended for use by dental professionals to illuminate the oral cavity while performing examinations and dental procedures.
  • Manufacturer
    Pelton & Crane / Marus / DCI Equipment / KaVo

Manufacturer

Pelton & Crane / Marus / DCI Equipment / KaVo
  • Dirección del fabricante
    Pelton & Crane / Marus / DCI Equipment / KaVo, 11727 Fruehauf Dr, Charlotte NC 28273-6507
  • Source
    USFDA