Philips Evolution Upgrade 3.0T MRI Cross Reference Line Alignment Error
Philips is recalling Evolution Upgrade 3.0T MRI systems (Models 782117 and 782143) due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a functionality error in image review tools that could affect diagnostic accuracy but is correctable and does not pose immediate structural or patient safety risk. The source text does not indicate hospitalization or serious injury reports.
Plain-English summary
Philips North America LLC is recalling the Evolution Upgrade 3.0T MRI system (Model Numbers 782117 and 782143) worldwide. The recall addresses a potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
The recall affects 28 units total (5 in the US and 23 outside the US), with distribution to the United States and numerous countries worldwide including Canada, the United Kingdom, Australia, Japan, and South Korea, among others. Affected serial numbers are listed for each model.
Users of the affected systems should contact Philips North America LLC for guidance on addressing this alignment issue. Clinicians should be aware that cross reference line alignment errors could affect image review accuracy when using the MobiView application.
The recalled product
- Product
- Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — MRI System
- Hazard
- alignment-error
- image-review-defect
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)
- Model Numbers: (1) 782117
- (2) 782143
- UDI-DI: (1) 00884838099739
- (2) 00884838108660
- Serial Numbers: (1) 42023
- 42024
- 42078
- 42375
- 42402
- 42408
- 71348
- 85675
- 85687
- 85694
- 85705
- (2) 42193
- 42225
- 42308
- 42320
- 42366
Distribution
Distributed nationwide across the United States.
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