Recalls / —
—#200696
Product
Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS
- FDA product code
- JAK — System, X-Ray, Tomography, Computed
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K191394
- Affected lot / code info
- UDI-DI: 10884521782211; Serial Number: 518503
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.
Root cause (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Covidien, LLC
- Address
- 161 Cheshire Ln N, Ste 100, Minneapolis, Minnesota 55441-5433
Distribution
- Distribution pattern
- International distribution in the country of Taiwan.
Timeline
- Recall initiated
- 2023-05-22
- Posted by FDA
- 2023-06-26
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #200696. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.