FDAClass IIIJanuary 31, 2024

Ingenia Ambition X recall

Ingenia Ambition X, Model No. 782109

Why was Ingenia Ambition X recalled?

An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.

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?

Model No. 782109 UDI-DI 00884838098350 Serial Number 47785

Product
Ingenia Ambition X, Model No. 782109
Recalling firm
Philips North America
Quantity
7 US; 16 ROW total
Distribution
Worldwide - US Nationwide distribution in the states of AR, CO, IL, MD, MS, NE, TX and the countries of Brazil, Canada, China, Germany, Greece, India, Mexico, and Saudi Arabia.
Recall date
January 31, 2024
Classification
Class III
Status
Ongoing
Agency
FDA (device)
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