Events

Alerta De Seguridad para CLINITEK Status, CLINITEK Status+, and CLINITEK Status Connect Systems

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Siemens.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2014-09-30
  • Fecha de publicación del evento
    2014-09-30
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140930.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: siemens clinitek status, clinitek status+, and clinitek status connect systems medicines and healthcare products regulatory agency (mhra), united kingdom, has issued a medical device safety alert concerning clinitek status, clinitek status+, and clinitek status connect systems, manufactured by siemens. the material numbers of affected products are identified as follows: clinitek status+: 10379675; 10379676; 10379677; 10379678; 10379679; 10379680; 10379681; 10697813; 10376324 (legacy p/n: 1780), clinitek status connect system: 10376322; 10376323 (legacy p/n: 1790); 10470849 (legacy p/n: 1797), clinitek status power supply adaptor – spare part: 10378632; 10378633; 10378634;10309177; 10309178; 10324040; 10376820 this affects power supply adaptors embossed with the numerical date codes: 50130, 51130, 52130, 01140, 02140, 03140, 04140, 05140, 06140, 07140, 08140, 09140, 10140, 11140, 12140, 13140, 14140, 15140, 16140, 17140, 18140, 19140, 20140, 21140, 22140, and 23140. the manufacturer has received customer complaints regarding damage to the external power supply adaptors that accompany the clinitek status, clinitek status+, and clinitek status connect urine analyzers, which can result in an increased potential for electric shock to the user. affected users are advised to discard all affected/ damaged adaptors. for clinitek status or clinitek status+ customers, instrument can still be run by battery power. affected users are suggested to consult operator’s guide for instructions. clinitek status connect systems, however, cannot be operated on battery power. for details, please refer to the following mhra website:http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con457620 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 30 sep 2014.

Device

CLINITEK Status, CLINITEK Status+, and CLINITEK Status Connect Systems
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Siemens CLINITEK Status, CLINITEK Status+, and CLINITEK Status Connect Systems
  • Manufacturer
    Siemens

Manufacturer

Siemens