Events

Retiro De Equipo (Recall) de Siemens Dimension Vista V-LYTE Intergrated Multisensor

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand 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
    20972
  • Fecha de inicio del evento
    2017-02-01
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Causa
    The manufacturer has confirmed a low bias for dimension vista v-lyte integrated multisensor urine potassium (k) when compared to the dimension quiklyte integrated multisensor, which is the predicate device used in the method comparison section of the v-lyte instructions for use (ifu). our testing showed a bias of -4.9% at a urine potassium concentration of 39.6 mmol/l, -19.6% at a urine potassium concentration of 32.8 mmol/l, and an average bias of -10.9% over the urine potassium concentration range of 7.5 to 133.7 mmol/l. this bias affects patient results, qc and could result in failures in accuracy-based proficiency testing program., the manufacturer is issuing this follow-up notification with enhanced instructions for updating and verifying the urine potassium method comparison coefficients.
  • Acción
    Software to be upgraded

Device

Siemens Dimension Vista V-LYTE Intergrated Multisensor

Manufacturer

Siemens Healthcare Diagnostics Inc
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    NZMMDSA