The Recall Desk
ModerateFDA (Devices)·Z-0112-2020·Announced 2019-10-16

GE Healthcare Recalls Achilles Bone Sonometers with Incorrect Power Cords

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.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The hazard involves incorrect power cords that may not provide proper protective earth connection, posing a potential electrical safety risk, but no injuries or deaths are reported in the source text.

Plain-English summary

GE Healthcare, LLC is recalling 599 Achilles Insight Bone Sonometers. The recall was initiated because certain 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 affected devices were distributed nationwide in the United States to Arizona, Georgia, Montana, North Carolina, New Jersey, New York, Ohio, and Wisconsin. The devices were also distributed internationally to numerous countries including Australia, Brazil, China, India, and the United Kingdom.

No specific instructions for consumers are provided in the source text. Users of these devices should contact GE Healthcare for further instructions regarding the replacement of the power cords.

The recalled product

Product
Achilles Insight Bone Sonometer
Manufacturer
GE Healthcare, LLC
Affected units
599

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • System ID: AWI33021
  • AWI33682
  • 0911LN0007
  • 091133NZM31481
  • 091133NZM31582
  • 091133NZM31875
  • BH1055US01
  • 0002860952
  • 0002868705
  • 83033603652009
  • 83033604564999
  • 0002657156
  • ACH+12941
  • ACH+12946
  • 084733NZM31677
  • 2644078
  • 82433040028
  • 82433040037
  • 82433070008
  • 82433120015

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Part of a larger recall action

This product is one of 2 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →