Events

Retiro De Equipo (Recall) de Device Recall Lumbar Matrix Scan (LMS)

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 SpineMatrix Inc.

¿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
    55796
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1935-2010
  • Fecha de inicio del evento
    2010-01-29
  • Fecha de publicación del evento
    2010-06-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91822
  • 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
    Diagnostic Electromyograph - Product Code IKN
  • Causa
    A full design review of the cersr system was conducted in 7/2009. the audit revealed numerous design verification tests that either did not pass or did not meet the design input requirement. one requirement found that it was possible for the physician to think they were reviewing one patients scan, but were actually reviewing a scan from a different patient. this event did not happen; however,.
  • Acción
    On 1/29/2010 all customers were provided a Voluntary Product Recall Notification letter that was sent via U.S. Postal Service Certified Mail and they were contacted by phone to arrange for pick up of the devices. The letter identified the affected product and described the problem. Customers are to check their inventory for the affected product and contact SpineMatrix Customer Service to receive instruction as to how to return the affected product, if the firm did not already contact the customer. Customers must complete the verification form and return it. Questions should be directed to Customer Service.

Device

Device Recall Lumbar Matrix Scan (LMS)
  • Modelo / Serial
    Model Number(s): AM-0001-08-0 (CERSR) and 02003 (Electrode Array). CERSR serial numbers - 1,3, 6, 8, 9, 11, 12, 12a, 13, 14, 17, 19, 20, 21, and 23. Electrode Array lot numbers: 112607-01, 112007-01, 112807-01, 112907-01, 120407-01, 120607-01, 120707-01, 121007-01, 121107-01, 121207-01, 121307-01, 030508-01, 031108-01, 031208-01, 031308-01, 031408-01, 031708-01, 031808-01, 032608-01, 032708-01, 032808-01, 040308-01, 040408-01, 040708-01, 041008-01, 041108-01, 041409-01, 041609-01, 111008-01, 111208-01, 111708-01, 071309-01, 111308-01, 111808-01, 041309-01, 041409-01, 091009-01, & 111309-01.
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution -- CA, OH, OR & TX.
  • Descripción del producto
    Lumbar Matrix Scan, Diagnostic Electromyography System consisting of the CERSR Electromyography System and Electrode Array; the system consists of two devices. The first is a system of capital equipment referred to as CERSR Electromyography System, which includes a cart. The second device is disposable electrodes arrays, which are single use devices, used with the capital equipment that is adhered to the patient for monitoring the bioelectric signals produced by the muscles. The disposable is referred to as the Electrode Array. CERSR Electromyography System is packaged in a reusable crate maintained by SMI. The Electrode Array is packaged in a sealed foil pouch. Both devices are non-sterile and the packaging is for protection from damage during shipping.
  • Manufacturer
    SpineMatrix Inc

Manufacturer

SpineMatrix Inc
  • Dirección del fabricante
    SpineMatrix Inc, 526 South Main St. Suite 311, Akron OH 44311
  • Source
    USFDA