Summary
The FDA issued a Class II for Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS by Covidien, LLC. 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 fu.
Details
Source
Device Recall
External ID
Z-2008-2023
Action Date
2023-07-05
Status
Ongoing
Category
device
Product Description
Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS
Lot/Code Info: UDI-DI: 10884521782211; Serial Number: 518503
Quantity Affected: 1 unit
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.
Distribution
International distribution in the country of Taiwan.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-22
Company
Minneapolis, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 367 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Covidien, LLC has 61 FDA actions in our database, including 41 recalls and 20 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Covidien, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Covidien, LLC have FDA actions?
Covidien, LLC has 61 FDA actions in our database, including 41 recalls and 20 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2008-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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