Z-0112-2020Class II

Achilles Insight Bone Sonometer

Name: Z-0112-2020 Achilles Insight Bone Sonometer
Creator: GE Healthcare, LLC
Published: 2019-09-03
License: https://open.fda.gov/license/

GE Healthcare / initiated 2019-09-03 / Terminated / root cause: design

FDA source

GE Healthcare, LLC began a recall of Achilles Insight Bone Sonometer on 2019-09-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0112-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-03
Posted: 2019-10-10
Terminated: 2021-02-16
Recalling firm: GE Healthcare
Product: Achilles Insight Bone Sonometer
Product code: MUA Bone Sonometer
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: GE Healthcare notified customers on about 09/03/2019, via "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were informed of two (2) safety issues. The first safety issue was that 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 issue could lead to an electric shock. There have been no reported injuries as a result of this issue. Specific safety instructions included to continue using the system after following the below instructions: 1. Inspect the power cord set used on your Achilles Express or Achilles Insight system and ensure its compatibility with your wall socket; 2. Use the European CEE 7/7 Type plug only with the two wall sockets because the protective earthing connection will not be established with any other socket; 3. Do not use any adapters with your plug or wall socket; 4. If you have a CEE 7/7 Type plug and a wall socket other than that shown in Figure 2 of the letter, discontinue use of your system. Your power cord set will be replaced with the correct power cord. Destroy the incorrect power cord to ensure it is not used. The second safety issue is that certain Achilles Express and Achilles Insight systems were shipped with 125V rated power cords (type B plug) to these countries where the mains voltage could be greater than 200V. This issue could lead to an electric shock. There have been no reported injuries as a result of this issue. Specific safety instructions included, that for certain systems in Peru, Philippines and Thailand, a power cord type B plug rated at 125V, as shown in Figure 3, was shipped. The mains voltage in these countries could be greater than 200V and, as a result, this plug should not be used. If you are located in one of these three countries with mains voltage greater than 200V and have the plug shown in Figure 3 of the letter, disconnect your Achil
Quantity in commerce: 599 devices
Distribution: Nationwide distribution to AZ, GA, MT, NC, NJ, NY, OH, WI. International distribution to Australia, Bahrain, Bangladesh, Brazil, Cambodia, Chile, China, Colombia, Cyprus, Hong Kong, India, Iraq, Ireland, Italy, Kuwait, Lebanon, Malaysia, Mauritius, Mexico, MEXICO, Myanmar, Nepal, Oman, Panama, Peru, Philippines, Saudi Arabia, Singapore, Sri Lanka, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Uruguay, Vietnam
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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0112-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0112-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-10
Z-0113-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-10

Product code MUA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)