Recall Z-2008-2023— Covidien, LLC

Name: FDA recall Z-2008-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-22

Class II · Ongoing

Class II FDA medical device recall by Covidien, LLC, initiated 2023-05-22. It names one FDA 510(k) clearance: K191394. Product: Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS. Reason: Single ILLUMISITE Platform Console was converted from a 220-240VAC model to a 120VAC configuration using a non-supplied power cord and non-supplied fuses in the field by Medtronic Field Service Engineer..

Recalling firm: Covidien, LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-05-22
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K191394 — ILLUMISITE PlatformCovidien, LLC·cleared 2019-08-07

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

Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS

Reason for recall

Single ILLUMISITE Platform Console was converted from a 220-240VAC model to a 120VAC configuration using a non-supplied power cord and non-supplied fuses in the field by Medtronic Field Service Engineer.

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