BEUDAMED
    FDA Recall Terminated

    Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808.

    Recall: Z-2111-2020 · Initiated April 2, 2020

    Recall

    Recall Number
    Z-2111-2020
    Event Number
    85536
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    FMZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 2, 2020
    Posted
    May 22, 2020
    Terminated
    May 6, 2024
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808.

    Reason

    During Giraffe Shuttle charging, the batteries emit low concentrations of gases (outgassing) producing a strong sulfur odor.

    Action

    GE Healthcare notified customers on 04/02/2020 via "Urgent Medical Device Correction" letter. The recall letter identified the affected product and serial numbers. The firm instructed the users to discontinue use of the product if at any time they smell a gas odor. GE Healthcare will correct all affected products at a later date when the correction is available at no cost.

    Distribution

    US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GA, ID, IL, IN, LA, MD, MI, MS, NC, ND, NM, NV, NY, OH, Ok, OR, PA, SC, TN, TX, VA, WA, WI and WV.

    Quantity

    204 units.