Z-0631-2024Class II

Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD

Name: Z-0631-2024 Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD
Creator: Covidien
Published: 2023-11-16
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2023-11-16 / Open, Classified / root cause: software

FDA source

Covidien began a recall of Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD on 2023-11-16. FDA classified it as Class II and gives the reason as "Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperable". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0631-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-16
Posted: 2024-01-03
Recalling firm: Medtronic, Inc.
Product: Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperable
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: On November 16 and 20, 2023, Covidien LLC (Medtronic Company) issued a "Urgent: Medical Device Correction" 1. Immediately notify all personnel in all care environments in which the Valleylab" FT10 Energy Platform. 2. Update ValleylabTM FT10 Energy Platform to software version 4.0.4. For additional information see customer communication letter 3. Until the software is updated, the Valleylab" FT10 Energy Platform and LigaSure" devices can continue to be used as instructed in the User Guide and per your facility protocols. 4. Complete the attached Customer Confirmation Form and return it as directed to confirm your receipt and understanding of this information.
Quantity in commerce: 47,901 units
Distribution: Worldwide distribution - US: Nationwide and surrounding territories.
Product codes and lots: Ref-UDI: VLFT10GEN- 10884521516328, DLVLFT10GEN - 10884521787056 , VLFT10GENZD - 10884521640474/Software: v4.0.1, v4.0.2 and v4.0.3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0631-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0631-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-10	2024-01-03

Product code GEI

K191601Class IIValleylab FT10 Electrosurgical PlatformCovidien / cleared 2019-07-12

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)