Events

Recall of Arkon Anesthesia Delivery System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Del Mar Reynolds Medical, Ltd..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77019
  • Event Risk Class
    Class 2
  • Event Number
    Z-2093-2017
  • Event Initiated Date
    2017-04-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-10-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154830
  • Notes / Alerts
    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.
  • Extra notes in the data
    Gas-machine, anesthesia - Product Code BSZ
  • 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

Device

Arkon Anesthesia Delivery System
  • Model / Serial
    *********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.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US distribution in FL, LA, MS, NC, NC, SC and WY and Internationally to Panama and United Kingdom.
  • Product 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.
  • Manufacturer
    Del Mar Reynolds Medical, Ltd.

Manufacturer

Del Mar Reynolds Medical, Ltd.
  • Manufacturer Address
    Del Mar Reynolds Medical, Ltd., 1 2 Harforde Court John Tate Road, Business Park, Hertford United Kingdom
  • Manufacturer Parent Company (2017)
    OSI Systems Inc
  • Source
    USFDA