FDA-Device2019-10-16Class II
Achilles Insight Bone Sonometer
GE Healthcare, LLC
Hazard
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.
Sold states
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
Affected count
599 devices
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
Achilles Insight Bone Sonometer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0112-2020Don't want to check this manually?
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