Events

Rappel de Device Recall Pulse Oximeter

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 Masimo Corporation.

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
    64812
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1187-2013
  • Date de mise en oeuvre de l'événement
    2013-03-13
  • Date de publication de l'événement
    2013-04-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-06-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117114
  • 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
    Oximeter - Product Code DQA
  • Cause
    Masimo has identified a very small number (0.02%) of rad-8 devices with 20-pin patient cable connector that, when moved, can power off without the operator pressing the power button.
  • Action
    Masimo Corporation sent an Urgent Recall Notification letter dated March 8, 2013, to all affected customers The letter identified the product the problem and the action needed to be taken by the customer. 1.Customers were instructed to please promptly remove all Rad-8 device(s) from use and your inventory and segregate these devices. 2. Please call 1-800-326-4890 and select option 2 for Technical Services. Determine with Technical Services whether you will return the affected device(s) to Masimo for repair or if eligible, receive a repair kit. If you will return the device(s) for repair, obtain a Return Material Authorization Number (RMA number). 3. Complete the Tracking/Verification Form in Attachment 2 and fax it to Masimo at 1-949-297-7700, even if you do not have or intend to use the affected device(s). 4. If you are eligible and intend to repair units onsite fax the completed original form in Attachment 2 to Masimo at 1-949-297-7700. 5. If you have elected to return the affected device(s), and have an RMA number include the completed original Form in Attachment 2 with the returned device(s) and indicate the RMA number on the outside of the return-shipping box. We apologize for the inconvenience. Please be assured that Masimo is committed to consistently providing high quality products and services to you, our customers. We thank you for your patience and cooperation while we actively work to resolve this issue. . .

Device

Device Recall Pulse Oximeter
  • Modèle / numéro de série
    Catalog Number 9190 9193 9191 9192 9212 9213 9218 9219 9224 9282 9285 2883 9194
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the countries of Africa, Asia, Australia/New Zealand, Europe, Canada, Latin America, and Middle East / SW Asia.
  • Description du dispositif
    Rad-8 Pulse Oximeters || The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).
  • Manufacturer
    Masimo Corporation

Manufacturer

Masimo Corporation
  • Adresse du fabricant
    Masimo Corporation, Forty Parker, Irvine CA 92618
  • Société-mère du fabricant (2017)
    Masimo Corporation
  • Source
    USFDA