Events

Recall of Device Recall S/5 Aneshesia 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
    34050
  • Event Risk Class
    Class 2
  • Event Number
    Z-0857-06
  • Event Initiated Date
    2005-11-16
  • Event Date Posted
    2006-05-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-01-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43016
  • 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
    Aneshesia Delivery Unit - Product Code BSZ
  • Reason
    Alarm sound-it is possible that the audible alarms from the speaker from the datex-ohmeda s/5 anesthesia delivery unit (adu) machine may dampen or disappear as a result of normal handling of the anesthesia machine. visual alarms on the adu are unaffected by this condition. the dampening or absence of audible alarms on the adu may result in a delay in treatment.
  • Action
    Customers were sent a letter dated November 16, 2005, informing them of the possible alarm failure and giving them short term and long term solutions. Short term, clinicians are to: 1) check the audio alarm prior to use; and 2) use the ADU in conjunction with functioning anesthetic agent monitor. In the long term a GE Healthcare representative will contact the facility and schedule a visit to implement the corrective action at no charge.

Device

Device Recall S/5 Aneshesia Delivery Unit
  • Model / Serial
    6025108 thru 6025111, 6025114 thru 6025117, 6025119, 6025120, 6025122 thru 6025128, 6025130 thru 6025132, 6025134, 6025136, 6025137, 6035737, 6035738, 6035740 thru 6035745, 6035747, 6035751, 6035757, 6035758, 6035760, 6035762, 6035765, 6035772 thru 6035774, 6035784, 6048756 thru 6048761, 6048764, 6048847, 6048849, 6048853 thru 6048856 and 40300736
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide---USA-States of AZ, CA, IA, MI, TX, and WI ----International- Australia, Austria, Belgium, Finland, Germany, Israel, Italy, Jordan, Malaysia, Netherlands, Norway, Portugal, Slovakia, South Africa, and Turkey.
  • Product Description
    Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU)
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare
  • Manufacturer Address
    GE Healthcare, 3030 Ohmeda Drive, PO Box 7550, zip 53707-7550, Madison WI 53718
  • Source
    USFDA