FDA recall Z-0631-2024

Covidien · Class II · device

Product

Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD

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

Distribution

Worldwide distribution - US: Nationwide and surrounding territories.

Key facts

Status
Ongoing
Initiation date
2023-11-16
Report date
2024-01-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lafayette, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0631-2024