Events

Retiro De Equipo (Recall) de Device Recall Image1 SPIES XLINK Camera Control Unit (CCU)

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 Karl Storz Endoscopy.

¿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
    74515
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2134-2016
  • Fecha de inicio del evento
    2016-06-20
  • Fecha de publicación del evento
    2016-07-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-01-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147810
  • 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
    Endoscopic video imaging system/component, gastroenterology-urology - Product Code FET
  • Causa
    Potential electrical interference issue when the image1 spies x-link and image1 spies d1 camera head are used in conjunction with the dci video mediastinocope and an electro-surgery generator (esg).
  • Acción
    KARL STORZ sent an Customer Notification letter dated June 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. KARL STORZ has become aware become aware of a potential electrical interference issue when the lmage1 SPIES X-LINK and lmage1 SPIES D1 camera head are used in conjunction with the DCI Video Mediastinoscope and an electro-surgery generator (ESG). Customers are instructed to complete the attached acknowledgement Form and to return it to KARL STORZ. Customers with questions are instructed to contact Technical Support Dept. at (800) 421-0837, press 2, and then press 1.

Device

Device Recall Image1 SPIES XLINK Camera Control Unit (CCU)
  • Modelo / Serial
    NT743473-P NT743472-P NT742840-P XU738911-P YU741045-P XU738248-P WU737260-P PV715203-P PV715207-P NT742829-P XU738899-P WU737275-P YV724235-P WU737269-P WU737268-P VU736411-P XU738901-P XU738910-P ZU742677-P YU741050-P VU736405-P TU733422-P TU733419-P SU733063-P VU736390-P VU736386-P UU734392-P RV716122-P OT744400-P NT743287-P OT744395-P NU727551-P NU727552-P NU727706-P TU734218-P TU734217-P NT742846-P YU741046-P OU728667-P TU733735-P VU736388-P NT742848-P NT742838-P OU728672-P OU728427-P WU737813-P OU729135-P OU728431-P OU728430-P WU737805-P ZU742670-P ZU742671-P YU741049-P YU740475-P ZU742681-P RV716116-P SU733055-P SU733057-P SU733059-P SU733060-P TU733418-P TU733420-P TU733421-P TU733423-P TU733424-P TU733425-P TU733427-P WU737810-P XU738914-P YU740004-P YU740471-P YU740479-P YU740480-P YU741036-P NV711744-P PV715216-P OU728670-P NU726430-P OT744399-P OT744389-P OT744386-P YU739999-P YU740003-P YU740005-P UU734395-P YV724443-P YV724442-P YV724440-P YV724438-P YV724245-P
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution to the states of : IL, NM, TX, MD, TN, PA, FL, KY, MO, NY, MN, DC, MA, WI, CT, MI, ID, CO, GA, NJ and AR., and to the countries of : Argentina, Australia, Belgium, Bulgaria, China, Germany, Finland, Great Britain, India, Italy and Japan.
  • Descripción del producto
    Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when used with Image1 SPIES D1 camera head, Product Model No. TH116 & TH115, and DC1 Video Mediastinoscope
  • Manufacturer
    Karl Storz Endoscopy

Manufacturer

Karl Storz Endoscopy
  • Dirección del fabricante
    Karl Storz Endoscopy, 2151 E Grand Ave, El Segundo CA 90245-5017
  • Empresa matriz del fabricante (2017)
    Karl Storz SE & Co. KG
  • Source
    USFDA