CLASS II ONGOING Device recall · Reported 28 May 2025 · FDA Enforcement Report
Ingenia Elition recalled by Philips North America
Philips North America is recalling Ingenia Elition S, distributed nationwide in the US. The recall was initiated on 13 May 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1802-2025
- FDA event ID
- 96889
- Recalling firm
- Philips North America, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 May 2025
- FDA classified
- 16 May 2025
- Reported
- 28 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 13 May 2025 | Recall initiated by company | |
| 16 May 2025 | Classified by FDA | +3 days |
| 28 May 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Product as listed by the FDA
Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;
Where it was distributed
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.
Questions about this recall
Why was it recalled?
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Which lots are affected?
Model Numbers: (1) 781357, (2) 782106, (3) 782137; UDI-DI: (1) 00884838088108, (2) 00884838098329, (3) 00884838108615; Serial Numbers: (1) 46002, 46004, 46007, 46012, 46013, 46015, 46016, 46018, 46020, 46021, 46023, 46025, 46039, 46049, 46054, 46068, 46076, 46082, 46085, 46092, 46101, (2) 46203, 46206, 46207, 46208, 46209, 46219, 46220, 46225, 46235, 46237, 46241, 46242, 46243, 46245, 46258, 46268, 46269, 46270, 46286, 46292, 46326, (3) 64001, 64002, 64003, 64004, 64005, 64007, 64008, 64009, 64011, 64013, 64014, 64015, 64016, 64019, 64022, 64023, 64024, 64028, 64029, 64030, 64032, 64034, 64045;
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
17 other products · FDA event 96889This product is part of a recall event; the main page for the event is Evolution Upgrade 3.0T recalled by Philips North America.
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All 558| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | SmartPath to dStream for XR and 3.0T recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
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| Device | CLASS II | Ingenia Elition S and Ingenia Elition recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
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