Events

Retiro De Equipo (Recall) de ReliaMed Deluxe Portable Adjusting Table

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 MDC Acquisition Co..

¿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
    55772
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2288-2010
  • Fecha de inicio del evento
    2010-04-23
  • Fecha de publicación del evento
    2010-08-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91751
  • 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
    Chair and table, medical - Product Code FPS
  • Causa
    Two complaints were received of the vinyl-covered, padded, plywood table surface breaking near the foot end.
  • Acción
    "Urgent: Medical Device Recall" letters were sent to consignees from Milliken Medical and Meyer Distributing Company in April 2010 describing the issue. They instructed their customers to immediately stop use of the table. customers were instructed to return the tables to the firm with an enclosed Recall Form for future replacement, or for replacement with a comparable table from another menufacturer at no cost, or for refund of the original cost of the device. Consignees may contact Meyer Distributing Company at 800-472-4221 and Milliken Medical at 800-532-1356.

Device

ReliaMed Deluxe Portable Adjusting Table
  • Modelo / Serial
    The table do not bear lot or serial numbers; however there are two device identification numbers representative of two different colors. ZZRNT100BL (blue) ZZRMT100BLK (black)
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA, including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA and WI, and the country of Canada.
  • Descripción del producto
    ReliaMed Deluxe Portable Adjusting Table. Product is a medical table used on patients for massage and chiropractic treatment.
  • Manufacturer
    MDC Acquisition Co.

Manufacturer

MDC Acquisition Co.
  • Dirección del fabricante
    MDC Acquisition Co., 8595 Milliken Ave Ste 101, Rancho Cucamonga CA 91730-4942
  • Source
    USFDA