Ingenia 3.0T CX MRI alignment error in MobiView image analysis
Philips recalls the Ingenia 3.0T CX MRI system due to potential alignment errors in the MobiView application's cross reference line function. The 37 affected units are located outside the United States.
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 medical device recall for potential alignment errors in diagnostic image analysis software. No reported injuries or adverse events. The issue represents a risk-of-harm product where harm has not yet been reported, meeting the criterion for High severity.
Plain-English summary
Philips North America LLC is recalling the Ingenia 3.0T CX magnetic resonance imaging (MRI) system, Model 781271. The recall affects 37 units located outside the United States across multiple countries including Canada, Australia, Japan, and the United Kingdom.
The recall is due to potential alignment errors in the cross reference line functionality of the MobiView application, which is used when reviewing images generated by the MRI system. These errors could affect the accuracy of image analysis.
No injuries or adverse events have been reported in connection with this issue. Affected facilities should contact Philips North America LLC for information regarding remediation and software updates.
The recalled product
- Product
- Product Name: Ingenia 3.0T CX; Model Number: 781271;
- Manufacturer
- Philips North America Llc
- Hazard
- alignment-error
- diagnostic-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 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.
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