Events

Rappel de Device Recall Reusable Ohmeda Compatible Finger Clip Sensor

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 Kentec Medical 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
    46397
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1188-2008
  • Date de mise en oeuvre de l'événement
    2007-05-18
  • Date de publication de l'événement
    2008-06-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-02-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67366
  • 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
    Oxygen Monitor - Product Code DQA
  • Cause
    Incompatible components: the finger clip sensors - with a serial number prefix of pa514, pa515, ye508, zc502 and zg512 - are missing an additional diode and higher resistor in its existing configuration making them inoperable when used to interface with those ohmeda tuffsat monitors previously re-configured by ohmeda to include a detection circuit for diodes.
  • Action
    Consignees were notified via telephone on 5/18/07 and an "Important Voluntary Market Withdrawal Notice" letter on 5/23/07. The letter instructed consignees to segregate and return all affected devices. The letter included an "Acknowledgement of Market Withdrawal Notification" form for customer to complete and return to the recalling firm. For additional information, contact 1-800-825-5996.

Device

Device Recall Reusable Ohmeda Compatible Finger Clip Sensor
  • Modèle / numéro de série
    Serial Numbers: YE508/001, YE508/002, YE508/003, YE508/004, YE508/005, YE508/006, YE508/007, YE508/008, YE508/009, YE508/010; ZC502/001, ZC502/002, ZC502/003, ZC502/004, ZC502/005, ZC502/006; ZG512/001, ZG512/002, ZG512/003, ZG512/004, ZG512/005, ZG512/006, ZG512/007, ZG512/008, ZG512/009, ZG512/010, ZG512/011, ZG512/012, ZG512/013, ZG512/014, ZG512/015; PA514/001, PA514/002, PA514/003, PA514/004, PA514/005, PA514/006, PA514/006, PA514/007, PA514/008, PA514/009, PA514/010; PA515/001, PA515/002, PA515/003, PA515/004, PA515/005, PA515/006, PA515/007, PA515/008, PA515/009, PA515/010, PA515/011, PA515/012, PA515/013, PA515/014, PA515/015, PA515/016, PA515/017, PA515/018, PA515/019, PA515/020, PA515/021, PA515/022, PA515/023, PA515/024, PA515/025, PA515/026, PA515/027, PA515/028, PA515/029, PA515/030, PA515/031, PA515/032, PA515/033, PA515/034 and PA515/035
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including states of AZ, CA, CO, FL, KY, LA, MA, NC, NJ, TX and UT.
  • Description du dispositif
    Reusable Ohmeda Compatible Finger Clip Sensor, Model Number: E403-02, Product Code: PS2225. To monitor oxygen saturation level of patients under doctor's care. Kentec Medical Inc., Irvine, CA 92614
  • Manufacturer
    Kentec Medical Inc

Manufacturer

Kentec Medical Inc
  • Adresse du fabricant
    Kentec Medical Inc, 17871 Fitch, Irvine CA 92614-6001
  • Société-mère du fabricant (2017)
    Kentec Medical Inc
  • Source
    USFDA