Events

Rappel de Device Recall Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit),

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 Merge Healthcare, 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
    76946
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1923-2017
  • Date de mise en oeuvre de l'événement
    2015-03-30
  • Date de publication de l'événement
    2017-05-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-05-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154651
  • 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
    Computer, diagnostic, programmable - Product Code DQK
  • Cause
    The units may display the alarm "sampling line clogged" after the flow zeroing procedure that is conducted automatically 1 hour after start up. this could result in the potential of a small bias added to the co2 measurement and affect the alarm notification.
  • Action
    The recall was initiated by telephone on March 30, 2015. Follow-up phone calls were made July 6, 2015. The firm was unable to provide a telephone script. The recalling firm also issued letters dated March 28, 2016, via email on April 6, 2016, dated July 11, 2016. The letters contained the same content, notified the customer of the issue, and informed them a fix was available. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. The notification also informs the customer their response is required using the enclosed form and the return addressed envelope. The response form asks, in part, if they have the affected ISA CO2 sensors at their facility and are they interested in accepting the fix. If they decline the fix, they are asked to provide the reason why. For further questions, please call (877) 741-5369.

Device

Device Recall Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit),
  • Modèle / numéro de série
    ISA CO2 Sensor serial numbers:  107349, 107357, 107358, 107363, 107370, 107377, 107390, 107407, 107435,  107476, 107509, 107510, 107556, 107659, 107700, 107707, 107768, 107776,  107831, 107832, 107836, 107839, and 107841.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution was made to medical facilities located in AL, FL, ID, LA, MO, NC, OK, SC, TX, and UT. There was government distribution and no foreign/military distribution.
  • Description du dispositif
    Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional accessory (sold separately) to the Merge Hemo Patient Data Module (PDM). The PDM is a major component of the Merge Hemo system.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.