Events

Rappel de Device Recall 115 V Blanketrol II, Model 222S HyperHypothermia System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Cincinnati Sub-Zero Products Inc.

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
    68356
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1679-2014
  • Date de mise en oeuvre de l'événement
    2014-01-08
  • Date de publication de l'événement
    2014-06-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-06-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127458
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Thermal regulation System - Product Code DWJ
  • Cause
    The incorrect voltage component was placed into the device during manufacturing. this may make the device unable to maintain patient temperature during cooling mode. the device will continue to indicate that the unit is cooling because the compressor will continue to run, however water in the reservoir will begin to return to ambient temperature. the actual water temperature will be displayed but.
  • Action
    The firm initiated a telephone notification on 01/08/2014, followed by a written notification which was sent to the customers via letter or email on 01/31/2014. URGENT Medical Device Field Action (January 31, 2014) REF: 115V Blanketrol II Model 22S Hyper-Hypothermia System (1) Discontinue Use and contact CSZ (2)Upon receipt of new 115V (p/n 91113) solenoid coil(s), immediately remove and destroy/discard all the affected 220V (p/n 3600) solenoid coil(s) (3)After the affected 220V (p/n 36007) solenoid coil(s) have been removed, discard and replaced, please complete and return the enclosed response form as soon as possible to acknowledge receipt of this notification and to imform CSZ that you have performed and completed the requested actions. Return the form by fax

Device

Device Recall 115 V Blanketrol II, Model 222S HyperHypothermia System
  • Modèle / numéro de série
    Model Number 222S; Serial #s: 133-2-00697, 133-2-00698; 133-2-00699; 133-2-00700; 133-2-00701; 133-2-00702; and 133-2-00703:.Part # 86165
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The product was distributed to one customer in MI, and internationally (Taiwan)
  • Description du dispositif
    115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165.
  • Manufacturer
    Cincinnati Sub-Zero Products Inc

Manufacturer

Cincinnati Sub-Zero Products Inc
  • Adresse du fabricant
    Cincinnati Sub-Zero Products Inc, 12011 Mosteller Rd, Cincinnati OH 45241-1528
  • Société-mère du fabricant (2017)
    Gentherm, Inc.
  • Source
    USFDA