Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW ve
Pending LLM rewrite. Source: FDA_DEVICE Z-1210-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
The recalled product
- Product
- Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.
- Manufacturer
- Philips North America
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 781356
- UDI-DI: 00884838090040
- Serial Numbers: 47206
- 47038
- 47068
- 47260
- 47294
- 47029
- 47189. (2) Product Code (REF): 782109
- UDI-DI: 00884838098350
- Serial Numbers: 47849
- 47634
- 47534
- 47726
- 47760
- 47706
- 47789
- 47642
- 47681
- 47761
Distribution
Distributed nationwide across the United States.
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