medical Class II Updated 2026-02-04

Philips North America recalls Ingenia Ambition S. Product Code (REF): 782108. MR syste

Recalled Product

Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.


Hazard / Issue

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: MR systems with SW version R11.1 and R12.1. Product Code (REF): 782108. UDI-DI: 00884838098343. Serial Numbers: 48669.
View official government recall

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