BEUDAMED
    FDA Recall Terminated

    Achilles Insight Bone Sonometer

    Recall: Z-0112-2020 · Initiated September 3, 2019

    Recall

    Recall Number
    Z-0112-2020
    Event Number
    83811
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    MUA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 3, 2019
    Terminated
    February 16, 2021
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Achilles Insight Bone Sonometer

    Reason

    Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Power Cords to countries where three protruding pin plugs are required for protective earth connection.

    Action

    GE Healthcare notified customers on about 09/03/2019, via "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were informed of two (2) safety issues. The first safety issue was that certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Power Cords to countries where three protruding pin plugs are required for protective earth connection. This issue could lead to an electric shock. There have been no reported injuries as a result of this issue. Specific safety instructions included to continue using the system after following the below instructions: 1. Inspect the power cord set used on your Achilles Express or Achilles Insight system and ensure its compatibility with your wall socket; 2. Use the European CEE 7/7 Type plug only with the two wall sockets because the protective earthing connection will not be established with any other socket; 3. Do not use any adapters with your plug or wall socket; 4. If you have a CEE 7/7 Type plug and a wall socket other than that shown in Figure 2 of the letter, discontinue use of your system. Your power cord set will be replaced with the correct power cord. Destroy the incorrect power cord to ensure it is not used. The second safety issue is that certain Achilles Express and Achilles Insight systems were shipped with 125V rated power cords (type B plug) to these countries where the mains voltage could be greater than 200V. This issue could lead to an electric shock. There have been no reported injuries as a result of this issue. Specific safety instructions included, that for certain systems in Peru, Philippines and Thailand, a power cord type B plug rated at 125V, as shown in Figure 3, was shipped. The mains voltage in these countries could be greater than 200V and, as a result, this plug should not be used. If you are located in one of these three countries with mains voltage greater than 200V and have the plug shown in Figure 3 of the letter, disconnect your Achil

    Distribution

    Nationwide distribution to AZ, GA, MT, NC, NJ, NY, OH, WI. International distribution to Australia, Bahrain, Bangladesh, Brazil, Cambodia, Chile, China, Colombia, Cyprus, Hong Kong, India, Iraq, Ireland, Italy, Kuwait, Lebanon, Malaysia, Mauritius, Mexico, MEXICO, Myanmar, Nepal, Oman, Panama, Peru, Philippines, Saudi Arabia, Singapore, Sri Lanka, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Uruguay, Vietnam

    Quantity

    599 devices