Medtronic ILLUMISITE Platform Console, Model Number… recallZ-2008-2023 · Covidien, LLC · initiated May 22, 2023
Class II Open, Classified All recalls posted in June 2023
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Covidien, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-2008-2023
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- May 22, 2023
- Posted by the FDA
- Jun 26, 2023
- Recalling firm
- Covidien, LLC
- Quantity
- 1 unit
- Product code
- JAK
- FDA submissions
- K191394
- Distribution
- International distribution in the country of Taiwan.
Product description
Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS
Code information (models, lots, serial numbers)
UDI-DI: 10884521782211; Serial Number: 518503
Other devices under the same FDA submission
7 devices cleared under K191394 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ILLUMISITE ILS-1000-CSCovidien LP · System, x-ray, tomography, computed1 death103 reports
- ILLUMISITE ILS-1800-KTCovidien LP · System, x-ray, tomography, computed93 reports
- ILLUMISITE ILS-0900-KTCovidien LP · System, x-ray, tomography, computed89 reports
- ILLUMISITE ILS-0450-KTCovidien LP · System, x-ray, tomography, computed14 reports
- ILLUMISITE ILS-1000-CSCovidien LP · System, x-ray, tomography, computed9 reports
- ILLUMISITE ILS-1000-CSCovidien LP · System, x-ray, tomography, computed1 death8 reports
- ILLUMISITE ILS-1000-CSCovidien LP · System, x-ray, tomography, computed2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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