MRI Imaging Device Software Alignment Error in Image Analysis
Philips Ingenia Elition X MRI systems potentially have software alignment errors in the MobiView image analysis application's cross reference line functionality. The recall affects 198 units distributed globally, including 25 in the United States.
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 FDA Class II medical device has potential for diagnostic error (alignment issues in image analysis) without any injuries mentioned in the source text, fitting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Philips North America LLC is recalling the Ingenia Elition X magnetic resonance imaging (MRI) system across three model numbers (781358, 782107, 782136) due to potential alignment errors in the MobiView application used for post-acquisition image review. The alignment error affects the cross reference line functionality used in image analysis.
The recall affects 198 units distributed worldwide, including 25 units in the United States and 173 units in other countries. Specific affected serial numbers are available from the manufacturer.
Healthcare facilities with affected equipment should contact Philips North America LLC for guidance on correcting the software alignment issue. The manufacturer will provide corrective action information directly to affected facilities.
The recalled product
- Product
- Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;
- 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) 781358
- (2) 782107
- (3) 782136
- UDI-DI: (1) 00884838088115
- (2) 00884838098336
- (3) 00884838108608
- Serial Numbers: (1) 45010
- 45023
- 45028
- 45029
- 45032
- 45033
- 45034
- 45037
- 45040
- 45041
- 45043
- 45045
- 45046
- 45048
Distribution
Distributed nationwide across the United States.
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