Reported Oct 16, 2019 · Terminated

Achilles Insight Bone Sonometer

GE Healthcare, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615

Is this the product you have?

  • Achilles Insight Bone Sonometer
Lot codes and dates
  • System ID

    599 of 599 codes

    • AWI33021
    • AWI33682
    • 0911LN0007
    • 091133NZM31481
    • 091133NZM31582
    • 091133NZM31875
    • BH1055US01
    • 0002860952
    • 0002868705
    • 83033603652009
    • 83033604564999
    • 0002657156
    • ACH+12941
    • ACH+12946
    • 084733NZM31677
    • 2644078
    • 82433040028
    • 82433040037
    • 82433070008
    • 82433120015
    • 82433080005
    • 82433040035
    • 82433040039
    • 82433140020
    • 82433290005
    • 82433130044
    • 82433130045
    • 82433230011
    • 82433140022
    • 82433140023
    • 82433140021
    • 82433140016
    • 0002556007X
    • CY1121US01
    • 828330064
    • 828330102
    • 828330049
    • 828330082
    • 83033005100157
    • 0002752556
    • 83033825104417
    • 83033205101815
    • 83033209010045
    • IQ1287US02
    • IQ1084US01
    • IE1016LU04
    • IE1063LU02
    • IE1106LU02
    • IE1106LU03
    • IE1153US01
    • IE1131US01
    • A6165801
    • A185446001
    • A6141901
    • A5945702
    • B5313202
    • A6141801
    • A5807032
    • A167409101
    • A6089201
Amount recalled
599 devices

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 16, 2021 · Data as of Sep 19, 5:29 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.