Lower risk Medical device recall · FDA · Published November 16, 2023

Covidien Valleylab FT10 Energy Platform Software Error May Cause Inoperable System

Covidien recalls Valleylab FT10 Energy Platform systems with software v4.0.1-4.0.3 that may become inoperable due to a software error. Affected units include specific model references and serial numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0631-2024Medical device Covidien ›

Lower-risk recall

Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperable

Take action

Contact the company

Recalling firmCovidien200 Medtronic Dr · Lafayette, CO 80026

✎ GovInfoNow plain-language explainer

Covidien is recalling Valleylab FT10 Energy Platform systems with software versions 4.0.1 to 4.0.3. These systems may become inoperable due to a software error, preventing proper use. Read more at govinfonow.com/recall/56809-covidien-valleylab-ft10-energy-platform-software-error-may-cause-inoperable.

Source Summary by GovInfoNow · govinfonow.com/recall/56809-covidien-valleylab-ft10-energy-platform-software-error-may-cause-inoperable · Updated August 10, 2026 · FDA enforcement record: FDA #Z-0631-2024

Cite this page

“Covidien Valleylab FT10 Energy Platform Software Error May Cause Inoperable System.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/56809-covidien-valleylab-ft10-energy-platform-software-error-may-cause-inoperable. Based on FDA recall #Z-0631-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0631-2024%22&limit=1).

The FDA announced on November 16, 2023, that Covidien is recalling its Valleylab FT10 and FT Series Energy Platforms due to a software issue that may render the systems inoperable. The agency issued recall number Z-0631-2024 for the voluntary Class II recall.

How to tell if you have it

Brand: Covidien
Product: Valleylab FT10, FT Series Energy Platform
REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD
Ref-UDI: VLFT10GEN- 10884521516328, DLVLFT10GEN - 10884521787056 , VLFT10GENZD - 10884521640474
Software versions: v4.0.1, v4.0.2 and v4.0.3
Units affected: 47,901

The hazard

According to the FDA, a software issue may cause new systems to exhibit an error that prohibits use, resulting in the system being inoperable.

Context

GovInfoNow's records show Covidien has 14 other recalls on record since March 5, 2021. Other recent recalls include a June 23, 2025 recall of a Bedside SpO2 Monitor where alarms may not be heard and a May 21, 2025 recall of a Newport HT70 Ventilator due to risk of shutdown.

How to tell if you have this one

Check for the model references VLFT10GEN, DLVLFT10GEN, or VLFT10GENZD with software versions 4.0.1, 4.0.2, or 4.0.3. The product includes specific serial numbers listed in the recall notice.

Brand
Covidien
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify the software version on your Valleylab FT10 Energy Platform system. If it is 4.0.1, 4.0.2, or 4.0.3, it is affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US: Nationwide and surrounding territories.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 55 days after the firm started it.

Nov 16, 2023Firm started the recall
Jan 3, 2024FDA classified it Class II
Jan 10, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/56809-covidien-valleylab-ft10-energy-platform-software-error-may-cause-inoperable">Covidien Valleylab FT10 Energy Platform Software Error May Cause Inoperable System (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0631-2024 (November 16, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0631-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.