Events

Retiro De Equipo (Recall) de Quasar MD

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 Quasar Bio-Tech, Inc. dba Silver Bay LLC.

¿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
    63530
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0518-2013
  • Fecha de inicio del evento
    2012-10-25
  • Fecha de publicación del evento
    2012-12-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-05-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114185
  • 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
    Lamp, infrared, therapeutic heating - Product Code ILY
  • Causa
    Quasar bio-tech is recalling their baby quasar, baby quasar pink, quasar power pack, and quasar md because the device is unapproved.
  • Acción
    The firm, Quasar Bio-Tech, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated November 16, 2012 to its customers. All domestic customers were notified by Certified mail. The letter described the product, problem and actions to be taken. The customers were instructed to cease distribution and remove the products from sale; to complete and return the enclosed Response Form via e-mail to DeNette@quasarbiotech.com or fax to: Quasar Bio-Tech, Attn: Quality/Recall Coordinator: at 941-306-5816, and return all remaining stock to Quasar Bio-Tech at Quasar Bio-Tech Inc., Attn: Quality/Recall Coordinator, 1431 Tallevast Road, Sarasota FL 34243. If you have any questions, contact the Quality/Recall Coordinator at 941-306-5812, Monday-Friday from 9:00 am to 5:00 pm Eastern Standard time.

Device

Quasar MD
  • Modelo / Serial
    Quasar MD- Model QMD-101 UPC Code 837654072196, Batch # 11652, 11727, 2441, 11870, 11884, 11955, 11969, 12005, 12006, 12029, 12057, 13008, 13193, 13199, 13221, 13242, 13271, 13288, 13325, 13514, 13521.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including states of: AZ, CA, CO, FL, GA, HI, ID, IL, KS, MD, MI, MN, MO, NC, NJ, NY, NV, OH, OR, TN, TX, UT, VA, and WA; and countries of: Aruba, Canada, Cayman Islands, China, Estonia, Ireland, Malaysia, New Zealand, Singapore, Sweden, Taiwan, and United Kingdom.
  • Descripción del producto
    Quasar MD is an infrared LED lamp that is labeled in part: "***QUASAR MD***Bringing the Spa Home***Radiant and Youthful Skin***QUASAR MD INCLUDES***QUASAR MD***USER MANUAL***12 VOLT POWER SUPPLY***1 OZ PURE SILK SERUM***Made in the USA.***Five year warranty***" || The product emits energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.
  • Manufacturer
    Quasar Bio-Tech, Inc. dba Silver Bay LLC

Manufacturer

Quasar Bio-Tech, Inc. dba Silver Bay LLC
  • Dirección del fabricante
    Quasar Bio-Tech, Inc. dba Silver Bay LLC, 1431 Tallevast Rd, Sarasota FL 34243-5035
  • Empresa matriz del fabricante (2017)
    Silver Bay Llc
  • Source
    USFDA