Recall Z-0631-2024 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Covidien
Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD
| Date | Jan 3, 2024 (initiated Nov 16, 2023) |
| Status | Open, Classified |
| Reason | Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperable |
| 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 |
| Quantity | 47,901 units |
| Distribution | Worldwide distribution - US: Nationwide and surrounding territories. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191601 | Valleylab FT10 Electrosurgical Platform Covidien, Jul 12, 2019 |