Events

Retiro De Equipo (Recall) de Device Recall syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions.

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 Siemens Healthcare Diagnostics, 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
    62709
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2305-2012
  • Fecha de inicio del evento
    2012-05-29
  • Fecha de publicación del evento
    2012-08-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111471
  • 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
    Calculator/data processing module for clinical use - Product Code JQP
  • Causa
    When using the syngo quality control package the system may not perform as intended for multi-rule qc violation [e.G., 2(2s), 4(1s) and 10x], unless configured using the instructions on page 2 of the recall notification. qc status may not be flagged appropriately. if auto-verification rules are defined to hold patient results when qc status is out, the patient results will not be held as expecte.
  • Acción
    Siemens sent a Urgent Field Safety Notice letter dated May, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed the customers to re-set the Multi-Rule option and instructions are provided on how to do so. This recall notification also included a Field Safety Effectiveness check form to please fax to the Siemens Technical Solutions Center at 302-631-8467 BY June 15th.

Device

Device Recall syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions.
  • Modelo / Serial
    Version VA11B and all previously released versions.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    USA ( nationwide ) including the states of AZ, CA, FL, IL, KY, MD, MA, MN, MS, MO, NE, NH, NJ, NY, NC, OH, PA, TX, VA and WV.
  • Descripción del producto
    syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. || This device is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA