Philips Ingenia MRI Software Recall for Memory-Related Scan Termination
Philips is recalling Ingenia 3.0T and 3.0T CX MRI systems because a software issue can terminate examinations during image reconstruction if scan parameters exceed available system memory.
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. The hazard is a software malfunction that terminates scans, which is a functional defect rather than a direct physical injury risk. No injuries or illnesses are reported, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Philips North America LLC is recalling 1,447 Ingenia 3.0T and Ingenia 3.0T CX MRI systems. The affected units 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 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 issue.
Healthcare facilities should contact Philips North America LLC for instructions on how to resolve the software issue. Consumers are not directly affected by this recall as the devices are used in professional medical settings.
The recalled product
- Product
- Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3. 782103(3.0T), 4. 781271(3.0T CX), 5. 782105(3.0T CX);
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — MRI Systems
- Affected units
- 1,447
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): 781342(3.0T)
- UDI-DI: 884838055339
- Serial Numbers: 85106
- 71152
- 71526
- 71812
- 71179
- 71252
- 71328
- 71342
- 71419
- 71550
- 71551
- 71555
- 71557
- 71674
- 71693
- 71949
- 85036
- 85155
Distribution
Distributed nationwide across the United States.
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