BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESTATION 620

    MDR report key: 25024421 · Received April 29, 2026

    Report

    Report Number
    9710602-2026-01180
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    April 13, 2026
    Report Date
    April 29, 2026
    Manufacturer
    GE MEDICAL SYSTEMS (CHINA) CO., LTD
    Product Code
    BSZ
    UDI-DI
    00840682103985
    PMA / PMN Number
    K151570
    Removal / Correction Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE (GEHC) REPORTED A FIELD MODIFICATION FOR AN ISSUE THAT PREVENTS EFFECTIVE MECHANICAL VENTILATION IN VOLUME CONTROL VENTILATION (VCV) MODE PER 21 CFR 806 ON 02-APR-2025. THE FDA RECALL NUMBERS ARE: Z-1624-2025, Z-1625-2025, Z-1626-2025, Z-1627-2025, Z-1628-2025, Z-1629-2025, Z-1630-2025, Z-1631-2025, Z-1632-2025, Z-1633-2025, Z-1634-2025, Z-1635-2025, Z-1636-2025, Z-1637-2025, Z-1638-2025. CUSTOMERS WERE SENT A LETTER EXPLAINING THE ISSUE AND PROVIDING INSTRUCTIONS FOR INSPECTING FOR EFFECTIVE VENTILATION IN VOLUME CONTROL VENTILATION (VCV) MODE. GEHC WILL CORRECT ALL DEVICES THAT FAIL THE VENTILATION SCREENING TEST AT NO COST. BLOCK A: NO PATIENT INVOLVEMENT. LEGAL MANUFACTURER: HCS MADISON - 3030 OHMEDA DR, USA MADISON, WI 53718.

    Description of Event or Problem · 0

    AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF THE CORRECTION INITIATED BY GE HEALTHCARE (GEHC) ON 02-APR-2025, (RECALL NUMBERS Z-1624-2025, Z-1625-2025, Z-1626-2025, Z-1627-2025, Z-1628-2025, Z-1629-2025, Z-1630-2025, Z-1631-2025, Z-1632-2025, Z-1633-2025, Z-1634-2025, Z-1635-2025, Z-1636-2025, Z-1637-2025, Z-1638-2025) THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE THAT PREVENTS EFFECTIVE MECHANICAL VENTILATION IN VOLUME CONTROL VENTILATION (VCV) MODE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27275 CARESTATION 620 ANESTHESIA GAS MACHINE BSZ GE MEDICAL SYSTEMS (CHINA) CO., LTD A1 NA 00840682103985

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown