Events

Retiro De Equipo (Recall) de Device Recall Apollo Therapy Laser

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 Pivotal Health Solutions.

¿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
    70473
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1250-2015
  • Fecha de inicio del evento
    2014-12-17
  • Fecha de publicación del evento
    2015-03-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-03-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133854
  • 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
    Control units were equipped with an internal mounting kit that does not meet medical safety standards, and are conductive, increasing the risk of electric shock to the user and patient. these units were manufactured prior to pivotal health solutions acquisition of the apollo product line.
  • Acción
    The firm, Pivotal Health Solutions, sent a letter dated December 17, 2014 on 12/17/2014 and an amended Pivotal "Urgent Medical Device Recall" letter dated February 9, 2015 to its consignees/customers. The letters described the product, problem and actions to be taken. The consignees/customers were instructed to stop using the unit and contact Pivotal Health Solution's at 1-800-743-7738 to arrange for return and repair asap; immediately examine your device inventory and quarantine any product subject to recall; if you have further distributed the product, identify your customers and notify them at once of this product recall, and complete and return the enclosed RETURN AUTHORIZATION FORM with the units to Pivotal Service Center, 1654 Mardon Drive, Dayton, OH 45432 and the DECLARATION OF CONTAMINATION STATUS form via Fax to: 605-882-8398. If you have any questions, contact Pivotal Health Solutions Service Repair Coordinator at 800-743-7738 or email Robin@PivotalHealthSolusitons.com.

Device

Device Recall Apollo Therapy Laser
  • Modelo / Serial
    DT-1102, 1105, 1106, 1109, 1110, 1112,1114, 1115, 1116, 1118,1119, 1120, 1121, 1121, 1122, 1123, 1124, 1125, 1126, 1127, 1128, 1129, 1130, 1131, 1132, 1134, 1135, 1136, 1137, 1138, 1139, 1302, 1303, 1304, 1309.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to states of: AZ, AR, CA, GA, IL, IN, IA, KS, MI, MN, MO, NY, OH, OR, PA, UT and WA.
  • Descripción del producto
    Apollo (cold) Laser Desktop Control Units, Model AP2-DT. || The Apollo IR Heat Lamp System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and / or promoting relaxation of muscle.
  • Manufacturer
    Pivotal Health Solutions

Manufacturer

Pivotal Health Solutions
  • Dirección del fabricante
    Pivotal Health Solutions, 724 Oakwood Road, Watertown SD 57201-4133
  • Empresa matriz del fabricante (2017)
    Pivotal Health Solutions
  • Source
    USFDA