Device product
Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD
Z-0631-2024
Product summary
- Firm
- Covidien
- Event
- Event 93561
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 47,901 units
- Official record key
device-enforcement:Z-0631-2024
Official wording
Reason: Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperable
Code information: Ref-UDI: VLFT10GEN- 10884521516328, DLVLFT10GEN - 10884521787056 , VLFT10GENZD - 10884521640474/Software: v4.0.1, v4.0.2 and v4.0.3
Distribution pattern: Worldwide distribution - US: Nationwide and surrounding territories.
Derived failure modes
-
Device software or design
software issue, New systems may exhibit an error