BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0239-2023 · Reported November 23, 2022

    Enforcement

    Recall Number
    Z-0239-2023
    Event ID
    91018
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Getinge Usa Sales Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 23, 2022
    Initiation Date
    October 14, 2022
    Classification Date
    November 15, 2022
    Address
    1 Geoffrey Way, N/A, Wayne, NJ, 07470-2035, United States

    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.

    Code Info

    No UDI - product discontinued in 2008. Part Number 1140.20F0: Serial Nos. 3, 8, 9, 10 Part Number 1140,20AN: Serial No. 851

    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