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[Recalled] Achilles Express Bone Sonometer — Certain Achilles Express and Achilles Insight systems were shipped with Europea… | FDA 2019-09-03

recall fda device united-states

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

ProductAchilles Express Bone Sonometer
Brand / manufacturerGE Healthcare, LLC
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0113-2020
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date03 September 2019
EAN / barcode828330086

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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 Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from GE Healthcare, LLC

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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