SmartPath to Ingenia Elition X recall
Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;
Why was SmartPath to Ingenia Elition X 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 Numbers: (1) 782118, (2) 782144; UDI-DI: (1) 00884838099746, (2) 00884838108677; Serial Numbers: (1) 42072, 42194, 42306, 71019, 71025, 71050, 85661, 85676, (2) 42062, 42105, 42323, 42346, 42441, 71278, 71504, 71508;
- Product
- Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;
- Recalling firm
- Philips North America Llc
- Quantity
- 16 units (All OUS)
- 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)