Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS
- Company
- Covidien, Llc
- Recall Initiated
- May 22, 2023
- Posted
- June 26, 2023
- Recall Number
- Z-2008-2023
- Quantity
- 1 unit
- Firm Location
- Minneapolis, MN
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.
Lot / Code Info
UDI-DI: 10884521782211; Serial Number: 518503
Root Cause
Process control
Action Taken
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.