BEUDAMED
    FDA Recall Open, Classified

    Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN

    Recall: Z-0239-2023 · Initiated October 14, 2022

    Recall

    Recall Number
    Z-0239-2023
    Event Number
    91018
    Firm
    Getinge Usa Sales Inc
    FEI Number
    3013876692
    Product Code
    FQO
    Status
    Open, Classified
    Root Cause
    Equipment maintenance
    Initiated
    October 14, 2022
    Posted
    November 15, 2022
    Address
    1 Geoffrey Way, Wayne, NJ, 07470-2035

    Description

    Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN

    Reason

    The back rest may unintentionally drop suddenly, resulting in adverse health consequences if a patient were to fall on the floor head first and at a steep angle.

    Action

    On October 14, 2022, the firm notified affected customers through Urgent Medical Device Correction letters. Customers were provided with extra precautions to take in order to continue use of the device. If you have any questions, please contact your Getinge representative or call the Getinge Customer Support at (888) 943-8872 (select option 2), Monday through Friday, 8AM - 6PM ET.

    Distribution

    Worldwide - US Nationwide distribution in the states of MA, NJ, SC, and TN. The countries of Australia (AU), Austria (AT), Belgium (BE), Brazil (BR), Bulgaria (BG), Canada (CA), China (CN), Croatia (HR), Czech Republic (CZ), Denmark (DK), Estonia (EE), Finland (FI), France (FR), Germany (DE), Greece (GR), Hungary (HU), Indonesia (ID), Israel (IL), Italy (IT), Japan (JP), Jordan (JO), Kuwait (KW), Lithuania (LT), Luxembourg (LU), Mexico (MX), Montenegro (ME), Morocco (MA), Netherlands (NL), Norway (NO), Pakistan (PK), Peru (PE), Poland (PL), Portugal (PT), Romania (RO), Russia (RU), Saudi Arabia (SA), Slovenia (SI), South Korea (KR), Spain (ES), Sweden (SE), Switzerland (CH), Taiwan (TW), Thailand (TH), Tunisia (TN), Turkey (TR), United Arab Emirates (AE), United Kingdom (GB), Yemen (YE).

    Quantity

    5 US; 1008 OUS