Class 2 Device Recall ILLUMISITE Platform Console

• Date Initiated by Firm: May 22, 2023
• Date Posted: June 26, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2008-2023
• Recall Event ID: 92394
• 510(K)Number: K191394
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS
• Code Information: UDI-DI: 10884521782211; Serial Number: 518503
• Recalling Firm/ Manufacturer: Covidien, LLC; 161 Cheshire Ln N Ste 100; Minneapolis MN 55441-5433
• For Additional Information Contact: Medtronic Customer Service; 800-962-9888
• Manufacturer 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.
• FDA Determined Cause: Process control
• 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.
• Quantity in Commerce: 1 unit
• Distribution: International distribution in the country of Taiwan.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JAK