Recall Z-0113-2020 ยท MUA Bone Sonometer
GE Healthcare, LLC
Achilles Express Bone Sonometer
| Date | Sep 3, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| 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: |
| Quantity | 241 devices |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.