Recall archive / FDA device enforcement
Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS — FDA record Z-2008-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 22, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS
- 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.
- Classification
- Class II
- Recalling firm
- Covidien, LLC
- Quantity
- 1 unit
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2008-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 10884521782211; Serial Number: 518503 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution in the country of Taiwan.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jul 5, 2023
- Recall initiation date
- May 22, 2023
- Center classification date
- Jun 26, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.