Recall Z-0631-2024— Covidien

Name: FDA recall Z-0631-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-16

Class II · Ongoing

Class II FDA medical device recall by Covidien, initiated 2023-11-16. It names one FDA 510(k) clearance: K191601. Product: 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.

Recalling firm: Covidien
Classification: Class II
Status: Ongoing
Initiated: 2023-11-16
Firm location: Lafayette, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K191601 — Valleylab FT10 Electrosurgical PlatformCovidien·cleared 2019-07-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.