Events

Recall of DatexOhmeda S/5 Anesthesia Delivery Unit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare.

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
    50800
  • Event Risk Class
    Class 2
  • Event Number
    Z-1635-2009
  • Event Initiated Date
    2008-10-30
  • Event Date Posted
    2009-07-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77328
  • 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 for Anesthesia - Product Code BSZ
  • Reason
    Ge healthcare has received reports of breathing circuit or tubing misconnections of the anesthesia delivery unit (adu), that may impact patient safety.
  • Action
    A GE Healthcare "Urgent Medical Device Correction" letter was sent to consignees on 1/16/09. The letter was addressed to Health Care Administrator, Chief of Anesthesia and Director of Clinical Engineering. The letter described the Safety Issue; Affected Product Details; Safety Instructions, which include clinical personnel being properly trained on the correct connections of breathing circuit tubing and proper execution of System Checkout according to the ADU URMs; Product Correction and Contact Information.

Device

DatexOhmeda S/5 Anesthesia Delivery Unit
  • Model / Serial
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA including states of AL, AK, AZ, AR, CA, CO, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, VA, WA, and WI and countries of Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Bosnia & Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, England, Estonia, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Iraq, Ireland, Isle of Man (UK), Israel, Italy, Japan, Jordan, Kazahkstan, Kuwait, Latin America, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Paraguay, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Yemen.
  • Product Description
    Datex-Ohmeda S/5 Anesthesia Delivery Unit || Intended to provide general inhalation anaesthesia and ventilatory support to a wide range of patients. Intended for volume or pressure control, pressure support and synchronized intermittent mandatory (SIMV) ventilation modes.
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare
  • Manufacturer Address
    GE Healthcare, 9900 Innovation Drive, Wauwatosa WI 53226
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA