Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD
This recall is currently active, issued January 3, 2024. It was issued by Covidien.
- Company
- Covidien
- Recall Initiated
- November 16, 2023
- Posted
- January 3, 2024
- Recall Number
- Z-0631-2024
- Quantity
- 47,901 units
- Firm Location
- Lafayette, CO
- Official Source
- View on FDA website ↗
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
Distribution
Worldwide distribution - US: Nationwide and surrounding territories.
Lot / Code Info
Ref-UDI: VLFT10GEN- 10884521516328, DLVLFT10GEN - 10884521787056 , VLFT10GENZD - 10884521640474/Software: v4.0.1, v4.0.2 and v4.0.3
Root Cause
Software Manufacturing/Software Deployment
Action Taken
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.