Philips Ingenia MRI Software Recall for Image Reconstruction Failure
Philips is recalling 2,038 Ingenia 1.5T MRI systems worldwide due to a software issue that can terminate examinations during image reconstruction if specific scan parameters are manually adjusted.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries or illnesses, fitting the criteria for a moderate severity recall involving a software defect with no reported harm.
Plain-English summary
Philips North America LLC is recalling 2,038 Ingenia 1.5T, Ingenia 1.5T CX, and Ingenia 1.5T S MRI systems. The affected units are distributed worldwide, including across the United States and numerous international markets. The recall involves specific model numbers and serial numbers listed in the FDA record Z-3236-2026.
The recall is due to a software issue that can cause an examination to terminate during the image reconstruction process. This failure occurs if scan parameters are manually adjusted in a way that causes reconstruction requirements to exceed the available system memory. The source text does not report any injuries, illnesses, or deaths associated with this defect.
Healthcare facilities and users of these MRI systems should contact Philips North America LLC for instructions on how to resolve the software issue. The recall is classified as Class II by the FDA, indicating that the defect could cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T), 2. 781341(1.5T), 3. 781396(1.5T), 4. 782101(1.5T), 5. 782115(1.5T), 6. 782140(1.5T), 7. 781261(1.5T CX), 8. 781262(1.5T CX), 9. 781347(1.5T S);
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — MRI Systems
- Affected units
- 2,038
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)
- 1. Model Numbers (REF): 781315(1.5T)
- UDI-DI: 884838099715
- Serial Numbers: 61019
- 61140
- 61080
- 61067
- 61091
- 61114
- 61028
- 61039
- 61040
- 61041
- 61000
- 61002
- 61003
- 61006
- 61009
- 61017
- 61032
- 61058
Distribution
Distributed nationwide across the United States.
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