Philips Ingenia Elition X MRI System Alignment Error Recall
Philips has recalled specific Ingenia Elition X MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 injuries or illnesses. The hazard is a functional software or alignment issue with potential for misinterpretation rather than a direct harm mechanism, and no adverse clinical outcomes are documented in the source text.
Plain-English summary
Philips North America LLC is recalling certain Ingenia Elition X magnetic resonance imaging (MRI) systems with three model numbers: 781358, 782107, and 782136. The recall affects 198 units, including 25 units distributed in the United States and 173 units distributed internationally.
The systems are being recalled due to potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. This could affect image interpretation accuracy during clinical use.
Specific serial numbers for each model have been identified. Users of affected devices should contact Philips North America LLC for further instructions and guidance on addressing this issue.
The recalled product
- Product
- Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;
- Manufacturer
- Philips North America Llc
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.
Part of a larger recall action
This product is one of 18 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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