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Terminated

Achilles Express Bone Sonometer

FDA Recall Z-0113-2020 · Posted None

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeMUA
Date Initiated2019-09-03
Date Terminated2021-02-16
Product Quantity241 devices

Reason for Recall

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.

Firm 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

Root Cause

Device Design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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