Events

Rappel de STATIM 7000 CASSETTE STERILIZER

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par SCICAN LTD..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    105113
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2015-01-20
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    This recall has been initiated due to a part that is no longer available. this part is an rfid (radio-frequency identification) tag which is used in the chamber seal to monitor the number of cycles ran in order to inform the user when it is necessary to change the chamber seal. our current supplier of this part has decided to exit the rfid tag business and a suitable replacement was not found. therefore all future cassette seals will no longer contain the rfid tag (seals are regularly replaced by the user). when this tag ?s not present the machine will not allow a cycle to start with the current software. ln order to implement this change in the stat/m 7000 and remove the rfid tag from the cassette seal the rfid board software must be updated to allow the unit to run without an rfid tag in the cassette seal. this will be performed by trained technicians at the user site. there is no need for the unit to be returned to the manufacturer for this software update. the life of the seal is still 1000 cycles or every twelve months whichever comes first but no notification will be given on the unit once the tag is no longer present and the software has been updated. it will be the user's responsibility to monitor the number of cycles ran and the seal's performance. manual monitoring of seal replacement is a common practice for most steam sterilizers on the market.

Device

STATIM 7000 CASSETTE STERILIZER
  • Modèle / numéro de série
    Model Catalog: 01-702100 (Lot serial: >10 contact mfg.); Model Catalog: 01-702101 (Lot serial: >10 contact mfg.); Model Catalog: 01-702101-R (Lot serial: >10 contact mfg.); Model Catalog: 01-702101-L (Lot serial: >10 contact mfg.)
  • Description du dispositif
    STATIM 7000 CASSETTE STERILIZER
  • Manufacturer
    SCICAN LTD.

Manufacturer

SCICAN LTD.
  • Adresse du fabricant
    TORONTO
  • Société-mère du fabricant (2017)
    Scican Ltd
  • Source
    HC