Philips Ingenia Elition S MRI System Alignment Error Recall
Philips is recalling certain Ingenia Elition S MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
What this means for you
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: The FDA classification is Class II. The source text does not report any actual illnesses, injuries, or adverse events—only a potential for alignment errors in image review functionality. The hazard is theoretical and no harm has been documented, making this a precautionary recall appropriate for a Moderate severity rating.
Plain-English summary
Philips North America LLC is recalling certain Ingenia Elition S magnetic resonance imaging (MRI) systems (model numbers 781357, 782106, and 782137). The recall addresses a potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
A total of 65 units have been distributed: 6 units in the United States and 59 units outside the United States. The affected systems are distributed worldwide, including in countries such as Canada, Australia, Japan, the United Kingdom, and many others.
Healthcare facilities and clinicians using affected Ingenia Elition S systems should contact Philips North America LLC for further guidance on corrective actions or software updates to address this alignment functionality issue.
The recalled product
- Product
- Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — MRI System
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) 781357
- (2) 782106
- (3) 782137
- UDI-DI: (1) 00884838088108
- (2) 00884838098329
- (3) 00884838108615
- Serial Numbers: (1) 46002
- 46004
- 46007
- 46012
- 46013
- 46015
- 46016
- 46018
- 46020
- 46021
- 46023
- 46025
- 46039
- 46049
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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