BEUDAMED
    FDA Enforcement Class II Terminated

    Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person restricted to a sitting position.

    Recall: Z-0785-2013 · Reported February 13, 2013

    Enforcement

    Recall Number
    Z-0785-2013
    Event ID
    64044
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Invacare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 13, 2013
    Initiation Date
    September 10, 2012
    Classification Date
    February 4, 2013
    Termination Date
    May 13, 2014
    Address
    1 Invacare Way, N/A, Elyria, OH, 44035-4190, United States

    Description

    Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person restricted to a sitting position.

    Reason

    The potential exists for the wheel to rotate freely despite engagement of hub brake.

    Code Info

    Model #3G, Serial numbers: 12GE003750, 12GE003554 and 12HE001766.

    Distribution

    US Nationwide Distribution including the states of CA & MT.

    Quantity

    3 units