Events

Alerte De Sécurité sur CLINITEK Status, CLINITEK Status+, and CLINITEK Status Connect Systems

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Siemens.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2014-09-30
  • Date de publication de l'événement
    2014-09-30
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140930.html
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Siemens CLINITEK Status, CLINITEK Status+, and CLINITEK Status Connect Systems
  • Manufacturer
    Siemens

Manufacturer

Siemens