FDAClass IIMay 29, 2024

Evolution upgrade 3.0T recall

Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143

Why was Evolution upgrade 3.0T recalled?

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: N/A Serial Numbers: 42246 85713 42029 71774 85668 85680 85685 85694 85705 42023 42024 42375 42217 42402 71044 85698 85700 85146 85677 85699 71595 71815 85649 42320 85684 71836 85679 85682 85697 85701 85708 85714

Product
Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143
Recalling firm
Philips North America Llc
Distribution
Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.
Recall date
May 29, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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