BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-2093-2017 · Initiated April 14, 2017

    Recall

    Recall Number
    Z-2093-2017
    Event Number
    77019
    Firm
    Del Mar Reynolds Medical, Ltd.
    FEI Number
    3010157426
    Product Code
    BSZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 14, 2017
    Terminated
    October 16, 2017
    Address
    2 Harforde Court John Tate Road, 1 Business Park Hertford United Kingdom

    Description

    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.

    Reason

    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

    Distribution

    US distribution in FL, LA, MS, NC, NC, SC and WY and Internationally to Panama and United Kingdom.

    Quantity

    62 total (US= 19 devices and 32 kits; International = 11 devices)