ILLUMISITE Platform Console Incorrectly Converted with Non-Supplied Power Components
A Medtronic ILLUMISITE Platform Console was modified from 220-240VAC to 120VAC using non-supplied power cord and fuses, creating electrical hazards. One unit was distributed to Taiwan.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II medical device with potential electrical hazards from improper voltage conversion using non-supplied components. This represents a risk-of-harm scenario where the hazard is theoretical rather than realized based on the source document.
Plain-English summary
A Medtronic ILLUMISITE Platform Console (Model ILS-1000-CS, Serial 518503) is being recalled. One unit was converted from a 220-240VAC model to a 120VAC configuration using a non-supplied power cord and non-supplied fuses by a Medtronic Field Service Engineer.
The use of non-supplied power components for voltage conversion creates electrical hazards. The converted configuration does not utilize FDA-approved components or procedures and poses risks including potential electrical fire, electrical shock, and device malfunction.
The affected unit was distributed internationally to Taiwan. Customers should contact Medtronic for guidance on proper resolution of the device.
The recalled product
- Product
- Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS
- Manufacturer
- Covidien, LLC
- Category
- Medical Device
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 10884521782211
- Serial Number: 518503
Distribution
Distribution scope not specified by the agency.
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