Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R
Pending LLM rewrite. Source: FDA_DEVICE Z-1206-2026.
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 1.5T. Product Code (REF): (1) 781341, (2) 781396. 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 (13)
- MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 781341
- UDI-DI: 00884838055322
- Serial Numbers: 70311
- 84560
- 84403
- 84467
- 84462
- 70042
- 84433. (2) Product Code (REF): 781396
- UDI-DI: 00884838009820
- Serial Numbers: 41356
- 41354
- 41370.
Distribution
Distributed nationwide across the United States.
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