FDA (Devices) recall action 83811
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
GE Healthcare is recalling 599 Achilles Insight Bone Sonometers because they were shipped with European power cords that do not meet local safety requirements for protective earth connection.
GE Healthcare is recalling 241 Achilles Express Bone Sonometers because they were shipped with power cords that do not meet local safety requirements for protective earth connection.