BEUDAMED
    FDA Recall Terminated

    Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11.X UPGRADE KIT FRENCH, AISYS 10.X TO 11.X UPGRADE KIT GERMAN, AISYS 10.X TO 11.X UPGRADE KIT JAPANESE. Product Usage: The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.

    Recall: Z-0412-2019 · Initiated September 27, 2018

    Recall

    Recall Number
    Z-0412-2019
    Event Number
    81182
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    BSZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 27, 2018
    Posted
    November 9, 2018
    Terminated
    April 12, 2021
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11.X UPGRADE KIT FRENCH, AISYS 10.X TO 11.X UPGRADE KIT GERMAN, AISYS 10.X TO 11.X UPGRADE KIT JAPANESE. Product Usage: The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.

    Reason

    Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV backup ventilation mode. PSVPro Spontaneous Breathing Modes do not provide the feature of transitioning to SIMV PCV backup ventilation mode for a patient who stops spontaneous breathing if the PSVPro ventilation mode is in use prior to the clinician starting the Cycling Procedure.

    Action

    GE Healthcare notified customers on about 09/27/2018 via "URGENT MEDICAL DEVICE CORRECTION" letter. The letter informed customers that they could continue to use the anesthesia device. The issue can only occur if the patient stops spontaneous breathing in PSVPro ventilation mode after completion of lung recruitment breaths. Stopping the Cycling Procedure resolves the issue. Continue to monitor patient as is normal for Apnea. A GE Healthcare representative will contact each customer to arrange for the correction. Questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

    Distribution

    Worldwide distribution - US nationwide in the states of CA, CO, DC, FL, GA, HI, IA, IL, IN, KY, LA, ,MA, MD, MI, MN, MO, MT, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV. Countries of Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea (Republic of), Kuwait, Macedonia, Mexico, Netherlands, New Zealand, Nigeria, Norway, Peru, Portugal, Qatar, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.

    Quantity

    4,207 units total