Events

Rappel de Arkon Anesthesia Delivery 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 Del Mar Reynolds Medical, 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
    77019
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2093-2017
  • Date de mise en oeuvre de l'événement
    2017-04-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-10-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154830
  • 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
    Gas-machine, anesthesia - Product Code BSZ
  • Cause
    Reports of the canister carrier breaking during absorbent exchange or during anesthesia machine transit, causing a leak in the breathing circuit, which could cause hypoventilation in the patient.
  • Action
    Spacelabs sent an URGENT - MEDICAL DEVICE CORRECTION letter dated April 13, 2017, to US customers via priority service. The customer letter (translated as necessary) will be emailed to all international subsidiaries and distributors of record on April 14, 2017. The letter announced that the The Arkon Anesthesia Delivery System, Model 99999, and the Absorber Adapter Assembly Kit part number 050-9045-00, and Absorber Adapter Assembly part number 650-1648-01 are being recalled. Customers are advised that The Arkon Anesthesia Delivery Systems Model 99999 with Absorber Adapter Assembly part number 650-1648-00 is NOT affected by this recall. Spacelabs Healthcare is developing a hardware upgrade to improve the robustness of the affected Absorber Adapter Assembly. A Spacelabs representative will contact consignees once the upgrade is available to schedule a convenient time to update their Arkon Anesthesia Delivery System(s) at no cost. For additional information or technical assistance, please contact: 1-800-522-7025 select 4 for Anesthesia Technical Support

Device

Arkon Anesthesia Delivery System
  • Modèle / numéro de série
    *********the serial numbers and part numbers of units distributed in the US *********  Absorber Adapter Assembly Service Kit part number: 050-9045-00.  Devices serial numbers: ARKN-000395, ARKN-000396, ARKN-000397, ARKN-000398, ARKN-000399, ARKN-000400, ARKN-000401, ARKN-000402, ARKN-000403, ARKN-000404, ARKN-000405, ARKN-000406, ARKN-000407, ARKN-000408, ARKN-000409, ARKN-000410, ARKN-000411, ARKN-000412, and ARKN-000413.  *********the serial numbers of units distributed international **************************  ARKN-000375, ARKN-000414, ARKN-000415, ARKN-000416, ARKN-000417, ARKN-000418, ARKN-000419, ARKN-000420, ARKN-000421, ARKN-000422, and ARKN-000423.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US distribution in FL, LA, MS, NC, NC, SC and WY and Internationally to Panama and United Kingdom.
  • Description du dispositif
    Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room. || Absorber Adapter Assembly Service Kit, part number: 050-9045-00. || Absorber Adapter Assembly, part number: 650-1648-01. || Arkon Absorber Canister Carrier, part number: 380-0916-01.
  • Manufacturer
    Del Mar Reynolds Medical, Ltd.

Manufacturer

Del Mar Reynolds Medical, Ltd.
  • Adresse du fabricant
    Del Mar Reynolds Medical, Ltd., 1 2 Harforde Court John Tate Road, Business Park, Hertford United Kingdom
  • Société-mère du fabricant (2017)
    OSI Systems Inc
  • Source
    USFDA