Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD
FDA device recall Z-0631-2024 · posted 2024-01-03 · Open, Classified
Recall details
- Recalling firm
- Covidien
- 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
- 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.
- Root cause
- Software Manufacturing/Software Deployment
- Status
- Open, Classified
- Product code
- GEI
- Quantity affected
- 47,901 units
- Distribution
- Worldwide distribution - US: Nationwide and surrounding territories.
- Date initiated
- 2023-11-16
- Date posted
- 2024-01-03
- Location
- Lafayette, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Valleylab FT10 Electrosurgical Platform (K191601) | Covidien | 2019-07-12 |