Z-2008-2023Class II

Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS

Name: Z-2008-2023 Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS
Creator: Covidien, LLC
Published: 2023-05-22
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2023-05-22 / Open, Classified / root cause: manufacturing process

FDA source

Covidien, LLC began a recall of Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS on 2023-05-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2008-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-22
Posted: 2023-06-26
Recalling firm: Medtronic, Inc.
Product: Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS
Product code: JAK System, X-Ray, Tomography, Computed
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 1 unit
Distribution: International distribution in the country of Taiwan.
Product codes and lots: UDI-DI: 10884521782211; Serial Number: 518503

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2008-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2008-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-26

Product code JAK

K191394Class IIILLUMISITE PlatformCovidien, LLC / cleared 2019-08-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)