GE Healthcare, LLC recalls Achilles Insight Bone Sonometer

Recall date

September 3, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0112-2020

FDA classification

Class II

Brand / firm

GE Healthcare, LLC

Sold / distributed

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…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Achilles Insight Bone Sonometer