Reported Feb 4, 2026 · Ongoing
Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.
Philips North America
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 · 222 Jacobs St · Cambridge, MA · 02141-2296
Is this the product you have?
- Ingenia Elition S
- Product Code (REF)(1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1
- Lot codes and dates
7 of 7 products
Products covered by this recall # Barcodes Product as published 1 781357 2 00884838088108UDI-DI: 00884838088108 3 Serial Numbers: 46002. (2) Product Code (REF): 782106 4 00884838098329UDI-DI: 00884838098329 5 Serial Numbers: 46243, 46292. (3) Product Code (REF): 782137 6 00884838108615UDI-DI: 00884838108615 7 Serial Numbers: 64034, 64045. - Amount recalled
- 5 units
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
Why it was recalled
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
This product could cause temporary or reversible health problems — stop using it.
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