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Recall Observatory FDA recall evidence

Device product

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

Z-2008-2023

May 22, 2023

Class II

Product summary

Firm
Covidien, LLC
Event
Event 92394
Status
Ongoing
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-2008-2023

Official wording

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.

Code information: UDI-DI: 10884521782211; Serial Number: 518503

Distribution pattern: International distribution in the country of Taiwan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.