Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R
Pending LLM rewrite. Source: FDA_DEVICE Z-1207-2026.
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 3.0T. Product Code (REF): (1) 781342, (2) 781377. 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): 781342
- UDI-DI: 00884838055339
- Serial Numbers: 71607
- 85216
- 71087
- 71619
- 71462
- 71002
- 71885
- 71841
- 71378
- 71269
- 85126
- 71279
- 71088
- 71185
- 71532
- 71344
- 71756
- 71336
Distribution
Distributed nationwide across the United States.
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