MRI System Cross-Reference Line Alignment Errors During Image Review
Philips Evolution Upgrade 3.0T MRI systems may display misaligned cross-reference lines when reviewing images with MobiView. This could compromise diagnostic accuracy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II recall involves a diagnostic imaging device with potential for misinterpretation if alignment errors affect image review. Although no illnesses or injuries have been reported, the risk of diagnostic error from misaligned reference lines constitutes a risk-of-harm scenario, satisfying the rubric criterion for High severity.
Plain-English summary
Philips North America LLC is recalling the Evolution Upgrade 3.0T MRI system (Model Numbers 782117 and 782143) due to potential alignment errors in the cross-reference line functionality when reviewing images with the MobiView application.
Cross-reference lines are essential guides that radiologists use to interpret MRI images accurately. When these lines are misaligned, they may not correctly correspond to patient anatomy, potentially leading to inaccurate image interpretation and affecting diagnostic decisions.
The recall affects 28 units distributed globally: 5 in the United States and 23 internationally across numerous countries. Affected devices can be identified by specific serial numbers referenced in the FDA recall notice.
Healthcare providers using affected devices should contact Philips for guidance regarding corrective actions, validation of prior image interpretations, or device replacement.
The recalled product
- Product
- Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;
- Manufacturer
- Philips North America Llc
- Hazard
- alignment-error
- diagnostic-error
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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