Philips Ingenia 1.5T CX MRI System Alignment Error Potential
Philips is recalling Ingenia 1.5T CX MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images with the MobiView application. This could affect image interpretation.
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 illnesses or injuries. The hazard is a potential alignment error in image review functionality, which represents a risk of misinterpretation rather than direct patient harm. No deaths, serious injuries, or hospitalizations are mentioned in the source text.
Plain-English summary
Philips North America LLC is recalling the Ingenia 1.5T CX magnetic resonance imaging (MRI) system, Model Number 781262. The recall addresses a potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Nine units of this device have been distributed worldwide, including throughout the United States and internationally to countries including Canada, Australia, Japan, and many others.
Users of the affected systems should contact Philips North America LLC for guidance on this issue and any recommended corrective actions. Users should not rely on the cross reference line functionality in the MobiView application until further notice from the manufacturer.
The recalled product
- Product
- Product Name: Ingenia 1.5T CX; Model Number: 781262;
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — MRI System
- Hazard
- Affected units
- 9
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 (11)
- Model Number: 781262
- UDI-DI: 00884838068445
- Serial Numbers: 77059
- 77120
- 77158
- 77161
- 77178
- 77182
- 77191
- 77193
- 77203
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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