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Open, Classified

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

FDA Recall Z-0631-2024 · Posted 2024-01-03

Recalling FirmCovidien
Recall StatusOpen, Classified
Product CodeGEI
Date Initiated2023-11-16
Product Quantity47,901 units

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

Firm 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.

Root Cause

Software Manufacturing/Software Deployment

Distribution Pattern

Worldwide distribution - US: Nationwide and surrounding territories.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K191601Valleylab FT10 Electrosurgical PlatformCovidien · 2019-07-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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