BEUDAMED
    FDA Enforcement Class I Ongoing

    GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012. Anesthesia system.

    Recall: Z-1630-2025 · Reported May 7, 2025

    Enforcement

    Recall Number
    Z-1630-2025
    Event ID
    96634
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Medical Systems China Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 7, 2025
    Initiation Date
    March 21, 2025
    Classification Date
    April 29, 2025
    Address
    Dev. Zone, National Hi-Tech; No. 19 Changjiang Road; Xin, Wuxi, N/A, China

    Description

    GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012. Anesthesia system.

    Reason

    Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.

    Code Info

    GTIN 00195278569684, Serial Numbers: SM724370002WC

    Distribution

    Worldwide distribution. US nationwide including Puerto Rico, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Fiji, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Malaysia, Maldives, Malta, Mexico, Moldova, Montenegro, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Oman, Pakistan, State of Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tonga, Trinidad Tobago, Tunisia, T¿rkiye, Uganda, Ukraine, UAE, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.

    Quantity

    1 unit