Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS
FDA device recall Z-2008-2023 · posted 2023-06-26 · Open, Classified
Recall details
- Recalling firm
- Covidien, LLC
- 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.
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- JAK
- Quantity affected
- 1 unit
- Distribution
- International distribution in the country of Taiwan.
- Date initiated
- 2023-05-22
- Date posted
- 2023-06-26
- Location
- Minneapolis, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ILLUMISITE Platform (K191394) | Covidien, LLC | 2019-08-07 |