Events

Retiro De Equipo (Recall) de Device Recall CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System

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 Boston Scientific Corporation.

¿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
    71398
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1817-2015
  • Fecha de inicio del evento
    2015-06-02
  • Fecha de publicación del evento
    2015-06-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-10-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137643
  • 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
    Amplifier and signal conditioner, transducer signal - Product Code DRQ
  • Causa
    Boston scientific has received complaints indicating that, when using the blood pressure (bp) channels on the clearsign ii amplifier, the surface electrocardiogram (ecg) channels become over-written to a variable degree, with the result that it appears shifted from baseline on the system's output screen. this may, in turn, manifest as an uninterpretable ecg signal in the affected channel.
  • Acción
    Boston Scientific sent an Important Field Safety Notification letter to all affected customers beginning June 3, 2015, by 24 hour overnight delivery. The letter identified the product the problem and the action needed to be taken by the customer. INSTRUCTIONS: 1. Please read carefully the Field Safety Notice letter and immediately post this information in a visible location near the product to ensure it is easily accessible to all users of the device. 2. Please complete the attached Verification Form even if you do not have any product to return. 3. When completed, please return the Verification Form to your local Boston Scientific Office to the attention of ¿Customer_Service_Fax_Number¿ on or before DATE 2015. 4. If you have products to return, and once a loaner unit is available, a Boston Scientific representative will coordinate with you to package the product being returned using a special shipping container. Your Competent Authority is being notified of this Field Safety Notice. We regret any inconvenience that this action may cause and we appreciate your understanding as we take action to ensure patient safety and customer satisfaction. If you have any questions or would like assistance with this Field Safety Notice, please contact your local Sales Representative. For further questions please call (978)-805-3200

Device

Device Recall CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System
  • Modelo / Serial
    Catalog number 2002021: lot numbers: EPYL0080, EPYL0118, EPZA0061, EPZA0072, EPZA0073, EPZA0074, EPZB0043, EPZC0019, EPZC0026, EPZC0027; Catalog number 2002022: lot numbers: EPYL0031, EPYL0032, EPYL0033, EPYL0034, EPYL0035, EPYL0036, EPYL0037, EPYL0038, EPYL0039, EPZA0062, EPZA0063, EPZA0079, EPZA0080, EPZB0049, EPZB0050, EPZB0051, EPZB0052, EPZB0056, EPZB0057, EPZB0058, EPZB0059, EPZB0065, EPZB0066, EPZB0067, EPZB0116, EPZB0117, EPZB0118, EPZC0018, EPZC0020, EPZC0021, EPZC0022, EPZC0023,EPZC0025, EPZD0013, EPZD0014, EPZD0015, EPZD0016, EPZD0017; Catalog number: 2002023: lot numbers: EPYL0082, EPYL0083, EPZA0064, EPZB0085, EPZB0119, EPZC0024, EPZD0018, EPZD0019, EPZD0020; Catalog number: 2002024; lot numbers: EPYL0082, EPYL0083, EPZA0064, EPZB0085, EPZB0119, EPZC0024, EPZD0018, EPZD0019, EPZD0020.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    No US distribution. Worldwide Distribution to the countries of : Austria, Belgium, France, Germany, Great Britain, Greece, Italy, Netherlands, Poland, Romania, South Africa, Spain, Switzerland and Turkey.
  • Descripción del producto
    CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08. The channel numbers in the amplifier are as follows: || Material number: H30120020210 - 40 Channel CLEARSIGN II Amplifier, catalog number 2002021; || Material number: H30120020220 80 Channel CLEARSIGN II Amplifier, catalog number 2002022; || Material number: H30120020230 120 Channel CLEARSIGN II Amplifier, catalog number 2002023; || Material number: H30120020240 160 Channel Clearsign II Amplifier, catalog number 2002014. || The CLEARSIGN II Amplifier is intended to amplify and condition electrocardiographic signals of biologic origin and pressure transducer input, transmitting this information to a host computer (the LABSYSTEM PRO EP Recording System) that can record and display the information
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Dirección del fabricante
    Boston Scientific Corporation, 55 Technology Drive, Lowell MA 01851-5203
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA