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Open, Classified

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

FDA Recall Z-2008-2023 · Posted 2023-06-26

Recalling FirmCovidien, LLC
Recall StatusOpen, Classified
Product CodeJAK
Date Initiated2023-05-22
Product Quantity1 unit

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.

Firm Action

Covidien notified the single consignee via letter on 05/18/2023. The consignee was instructed to quarantine and return affected product, forward the notification to those who need to be aware within the organization and to any location which the device has been transferred and complete and return the Customer Confirmation Form.

Root Cause

Process control

Distribution Pattern

International distribution in the country of Taiwan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K191394ILLUMISITE PlatformCovidien, LLC · 2019-08-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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