BEUDAMED
    FDA Enforcement Class II Terminated

    Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system

    Recall: Z-1788-2021 · Reported June 9, 2021

    Enforcement

    Recall Number
    Z-1788-2021
    Event ID
    87752
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Getinge (Suzhou) Co Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    June 9, 2021
    Initiation Date
    April 15, 2021
    Classification Date
    June 3, 2021
    Termination Date
    November 13, 2023
    Address
    NO 158 Fangzhoulu, Zhong Xin Gongyeyuanqu, Suzhou City, N/A, China

    Description

    Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system

    Reason

    There is a potential for abnormal inflation of the mattress.

    Code Info

    Model Numbers: 650001ADV, 650001DAR, 650001P, 650201DAR, 651001, 651001ADV, 651001DAR, 651001DARW, 651001P, 651201DAR, 651201P Product Code: 47478 (GMDN nomenclature code)

    Distribution

    USA

    Quantity

    13042 units