[pending] 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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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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