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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien Valleylab FT10, FT Series Energy Platform

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  Class 2 Device Recall Covidien Valleylab FT10, FT Series Energy Platform see related information
Date Initiated by Firm November 16, 2023
Date Posted January 03, 2024
Recall Status1 Open3, Classified
Recall Number Z-0631-2024
Recall Event ID 93561
510(K)Number K191601  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD
Code Information Ref-UDI: VLFT10GEN- 10884521516328, DLVLFT10GEN - 10884521787056 , VLFT10GENZD - 10884521640474/Software: v4.0.1, v4.0.2 and v4.0.3
Recalling Firm/
Manufacturer		 Covidien
200 Medtronic Dr
Lafayette CO 80026
For Additional Information Contact Medtronic Customer Service
800-962-9888
Manufacturer 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
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = Covidien
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