FDA Enforcement
Class II
Ongoing
Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD
Recall: Z-0631-2024
·
Reported January 10, 2024
Enforcement
- Recall Number
- Z-0631-2024
- Event ID
- 93561
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Covidien
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 10, 2024
- Initiation Date
- November 16, 2023
- Classification Date
- January 3, 2024
- Address
- 200 Medtronic Dr, N/A, Lafayette, CO, 80026, United States
Description
Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD
Reason
Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperable
Code Info
Ref-UDI: VLFT10GEN- 10884521516328, DLVLFT10GEN - 10884521787056 , VLFT10GENZD - 10884521640474/Software: v4.0.1, v4.0.2 and v4.0.3
Distribution
Worldwide distribution - US: Nationwide and surrounding territories.
Quantity
47,901 units