Events

Retiro De Equipo (Recall) de Device Recall Lipoplasty

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 Solta Medical Inc.

¿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
    77655
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3048-2017
  • Fecha de inicio del evento
    2017-06-01
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157189
  • 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
  • Causa
    Potential inaccurate calibration by service depot repair, which could contribute to patients being burnt by the device. this only impacts units serviced between the dates of 09/08/2016 and 05/23/2017.
  • Acción
    Consignees were telephoned on June 1, 2017, as initial recall notification. At that time, all consignees agreed to discontinue use of the affected product until it was returned or repaired. An Urgent Medical Device Recall letter dated June 14, 2017, requested that consignees that have not been contacted regarding this recall and have a device repaired between the dates of 09/08/2016 and 05/23/2017 contact Solta Medical immediately at 877-782-2286. Any questions regarding the recall can be directed to Solta Medical Product Support Team at 877-782-2286 or 510-259-5299, option 2.

Device

Device Recall Lipoplasty
  • Modelo / Serial
    Reference No. 110-0032; Shipping P/N P007014-03; Device P/N P007023-03; Serial No. 001CW9, 000V1W, 000VBK, VAS10-0135-SB, 001FM0, 000TJ5, 00190Q.
  • Distribución
    US Distribution to the states of : AL, CA, CO, FL, NY, PA, & TX.
  • Descripción del producto
    VASER PRO Amplifier, VASER 2.2 VASERlipo System stem, Rx Only, 115/230V - 60/50Hz 300VA || The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy).
  • Manufacturer
    Solta Medical Inc

Manufacturer

Solta Medical Inc
  • Dirección del fabricante
    Solta Medical Inc, 11720 N Creek Pkwy N Ste 100, Bothell WA 98011-8244
  • Empresa matriz del fabricante (2017)
    Bausch Health Cos., Inc.
  • Source
    USFDA