Recall Z-2008-2023 ยท JAK System, X-Ray, Tomography, Computed
Covidien, LLC
Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS
| Date | Jun 26, 2023 (initiated May 22, 2023) |
| Status | Open, Classified |
| 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. |
| Root 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 | 1 unit |
| Distribution | International distribution in the country of Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191394 | ILLUMISITE Platform Covidien, LLC, Aug 7, 2019 |