FDAClass IIMay 29, 2024

SmartPath to dStream for 3.0T recall

SmartPath to dStream for 3.0T Model Number (REF): 782145

Why was SmartPath to dStream for 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: 17377 34114 38294

Product
SmartPath to dStream for 3.0T Model Number (REF): 782145
Recalling firm
Philips North America Llc
Quantity
3 units
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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