Ingenia 3.0T CX MRI System Alignment Error in Cross Reference Line
Philips is recalling the Ingenia 3.0T CX MRI system due to potential alignment errors in the cross reference line when using the MobiView application to review images. The alignment error could affect image accuracy during review.
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: FDA Class II recall. The source text does not report any illnesses, injuries, or adverse events associated with the alignment error; the hazard is theoretical and relates to image-review accuracy rather than direct patient harm. This aligns with a Moderate severity classification.
Plain-English summary
Philips North America LLC is recalling the Ingenia 3.0T CX MRI system (Model Number 781271) due to a potential alignment error in the cross reference line functionality when reviewing images generated with the MobiView application.
The affected product is a magnetic resonance imaging (MRI) system. The issue involves potential misalignment of the cross reference line feature during image review, which could affect the accuracy of image interpretation.
37 units of this model have been distributed worldwide, including in the United States and numerous other countries. The affected units have specific serial numbers ranging from 78012 to 78287.
Customers who own or operate an affected Ingenia 3.0T CX system should contact Philips North America LLC for guidance on remediation or service options.
The recalled product
- Product
- Product Name: Ingenia 3.0T CX; Model Number: 781271;
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — MRI System
- Affected units
- 37
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 Number: 781271
- UDI-DI: 00884838068452
- Serial Numbers: 78012
- 78016
- 78017
- 78018
- 78025
- 78028
- 78033
- 78035
- 78039
- 78042
- 78045
- 78050
- 78053
- 78060
- 78062
- 78082
- 78095
- 78100
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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