Events

Recall of Device Recall 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
    67781
  • Event Risk Class
    Class 1
  • Event Number
    Z-1442-2014
  • Event Initiated Date
    2014-03-10
  • Event Date Posted
    2014-04-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126320
  • 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
    Ventilator, continuous, facility use - Product Code CBK
  • Reason
    The system may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence.
  • Action
    Spacelabs Healthcare sent an Urgent Medical Device Correction letter, dated 11 March 2014, to consignees. The letter identified the product, the problem, and the actions to be taken by the customer. The letter stated that Spacelabs Field Service personnel will be contacting consignees to schedule a convenient time to install, at no cost, a software upgrade. Consignees with questions about this corrective action program, please contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.

Device

Device Recall Arkon Anesthesia Delivery System
  • Model / Serial
    SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE US:  ARKN-000011, ARKN-000016, ARKN-000017, ARKN-000019, ARKN-000020, ARKN-000021, ARKN-000022, ARKN-000023, ARKN-000024, ARKN-000025, ARKN-000026, ARKN-000027, ARKN-000028, ARKN-000029, ARKN-000030, and ARKN-000031.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution in the states of North Carolina and South Carolina
  • Product Description
    SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
  • Manufacturer
    Del Mar Reynolds Medical, Ltd.

Manufacturer

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