FDA Medical Device Recalls (openFDA)
Covidien, LLC: Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS
- Recall number
- Z-2008-2023
- Recalling firm
- Covidien, LLC
- Product
- Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS
- Status
- Open, Classified
- Initiated
- 2023-05-22
- Posted
- 2023-06-26
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- UDI-DI: 10884521782211; Serial Number: 518503
- 510(k) numbers
- ["K191394"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 3004962788
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28