MRI Imaging System Alignment Error in Cross-Reference Line Image Review
Philips Ingenia Elition S MRI systems may display alignment errors in the cross-reference line when reviewing images via the MobiView application, potentially affecting image interpretation accuracy.
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: FDA Class II device recall with no reported illnesses or injuries. The hazard represents potential alignment errors in image review functionality that could impact diagnostic accuracy, fitting the criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips North America LLC has issued a recall for Ingenia Elition S MRI systems (Model Numbers 781357, 782106, and 782137). The devices may display alignment errors in the cross-reference line when images are reviewed using the MobiView application, potentially affecting the accuracy of image interpretation.
The recall affects 65 units globally, with 6 units distributed in the United States and 59 units in international markets. Specific serial numbers for each model variant are identified for this recall.
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
- Hazard
- alignment-error
- display-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) 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.
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