Reported May 28, 2025 · Ongoing
Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;
Philips North America LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America Llc · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
- Product NameIngenia Elition X
- Model Numbers
(1) 781358(2) 782107(3) 782136
- Lot codes and dates
- Model Numbers
(1) 781358(2) 782107(3) 782136
- UDI-DI
(1) 00884838088115(2) 00884838098336(3) 00884838108608
- Serial Numbers
198 of 198 codes
(1) 450104502345028450294503245033450344503745040450414504345045450464504845049450534506645070450724507645087450904509145092450934510245105451084511545116451194512745136451384514045144451474515445156451574516245168451814518445189451914519445205452224522745231452434524445245452464525045252452634527245277
- Model Numbers
- Amount recalled
- 198 units (25 US, 173 OUS)
This recall covers 18 products
The agency filed one notice per product. You are reading one of them; the other 17 are below.
5 more are in the archive.
Where it was sold
- Nationwide
- GA
Why it was recalled
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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