FDAClass IIMay 28, 2025

Ingenia 3.0T CX recall

Product Name: Ingenia 3.0T CX; Model Number: 781271;

Why was Ingenia 3.0T CX recalled?

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

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 Number: 781271; UDI-DI: 00884838068452; Serial Numbers: 78012, 78016, 78017, 78018, 78025, 78028, 78033, 78035, 78039, 78042, 78045, 78050, 78053, 78060, 78062, 78082, 78095, 78100, 78112, 78122, 78123, 78133, 78147, 78148, 78155, 78175, 78197, 78199, 78201, 78202, 78217, 78229, 78239, 78259, 78260, 78286, 78287;

Product
Product Name: Ingenia 3.0T CX; Model Number: 781271;
Recalling firm
Philips North America Llc
Quantity
37 units (OUS Only)
Distribution
Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.
Recall date
May 28, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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