Philips Ingenia MRI Software Recall for Image Reconstruction Failure
Philips is recalling 596 Ingenia Elition MRI systems due to a software issue that can terminate examinations during image reconstruction if system memory is exceeded.
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, illnesses, or deaths, aligning with the criteria for a moderate severity score.
Plain-English summary
Philips North America LLC is recalling 596 units of the Ingenia Elition S and Ingenia Elition X MRI systems. The affected model numbers are 781357(S), 782106(S), 782137(S), 781358(X), 782107(X), 782119(X), 782136(X), and 782158(X). These devices were distributed worldwide, including in the United States and numerous international markets.
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 should contact Philips North America LLC for instructions on how to resolve the software issue. Patients who have undergone scans on these systems should consult their healthcare provider if they have concerns about the integrity of their imaging results.
The recalled product
- Product
- Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137(S), 4. 781358(X), 5. 782107(X), 6. 782119(X), 7. 782136(X), 8. 782158(X);
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — MRI Systems
- Affected units
- 596
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): 781357(S)
- UDI-DI: 884838088108
- Serial Numbers: 46083
- 46045
- 46095
- 46119
- 46121
- 46024
- 46044
- 46055
- 46061
- 46052
- 46001
- 46005
- 46011
- 46048
- 46057
- 46060
- 46066
- 46078
Distribution
Distributed nationwide across the United States.
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