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Urgent Medical Device Correction: Medtronic/Covidien Valleylab FT10 FT Series Energy Platform
Urgent Medical Device Correction: Medtronic/Covidien Valleylab FT10 FT Series Energy Platform
Introduction:
Covidien, a leading manufacturer of electrosurgical generators, has issued a Class 2 urgent medical device correction for their Valleylab FT10 FT Series Energy Platforms.
FDA Recall Link:
Recall Scope:
REF/MODEL Numbers: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD. All systems running software: v4.0.1, v4.0.2 and v4.0.3.
Introduction:
Covidien, a leading manufacturer of electrosurgical generators, has issued a Class 2 urgent medical device correction for their Valleylab FT10 FT Series Energy Platforms.
FDA Recall Link:
Recall Scope:
REF/MODEL Numbers: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD. All systems running software: v4.0.1, v4.0.2 and v4.0.3.
Reason for Recall:
Covidien has stated that as a part of the investigation into this issue, it was noted that upon insertion of a new (unused) LigaSure™ device, the Valleylab™ FT10 Energy Platform running software versions 4.0.1, 4.0.2 and 4.0.3 may erroneously indicate that the LigaSure™ device was used previously. When this occurs, the energy platform will display error “E420 Usage Limit” or error “E416 Unknown Instrument,” and the LigaSure™ device would not be allowed to be used.
To address this issue, Covidien has made a software update available. Upgrading the Valleylab™ FT10 Energy Platform to the newly released software version 4.0.4 will eliminate this issue and the update is available for update to all Valleylab™ FT10 Energy Platforms, regardless of current software version.
FDA’s Determination:
The FDA has identified the software as the cause of the recall.
Recall Quantity:
The recall affects 47,901 units.
Recall Actions:
The following actions are listed in the Recall:
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.
Contact Information:
For additional information contact Medtronic Customer Service at 800-962-9888.