FDA recall Z-2008-2023

Product

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.

Distribution

International distribution in the country of Taiwan.

Key facts

Status

Ongoing

Initiation date

2023-05-22

Report date

2023-07-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2008-2023