Recall Z-0112-2020— GE Healthcare, LLC

Name: FDA recall Z-0112-2020
Creator: U.S. Food and Drug Administration
Published: 2019-09-03

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2019-09-03, terminated 2021-02-16. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2019-09-03
Terminated: 2021-02-16
Firm location: Waukesha, WI, United States

Product description

Achilles Insight Bone Sonometer

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.