The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0113-2020·Announced 2019-10-16

GE Healthcare Recalls Achilles Express Bone Sonometers Due to Power Cord Issue

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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: This is an FDA Class II recall involving a power cord defect that could pose a safety risk, but no injuries or illnesses have been reported, fitting the criteria for a moderate severity score.

Plain-English summary

GE Healthcare, LLC is recalling 241 Achilles Express Bone Sonometers. The recall is due to a defect in the power cords shipped with certain systems. Specifically, some units 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. The recall notice does not specify the exact number of devices in each location.

No injuries or illnesses have been reported in connection with this recall. Consumers and healthcare facilities should stop using the affected devices and contact GE Healthcare for instructions on how to obtain a replacement power cord or further assistance.

The recalled product

Product
Achilles Express Bone Sonometer
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Diagnostic Imaging
Hazard
Affected units
241

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: ACE34924
  • AWE11358
  • ACE34606
  • ACE34652
  • ACE34651
  • AWE11894
  • AWE1196
  • ACE34927
  • ACE886H
  • AWE10447
  • AWE11047
  • AWE11098
  • AWE11304
  • AWE11312
  • AWE11317
  • AWE11381
  • AWE11285
  • ACH+12937
  • ACH+12932
  • ACH+12939

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 →

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