Ingenia 1.5T MRI system alignment errors in image review
Philips Ingenia 1.5T MRI systems may display alignment errors in the cross-reference line when reviewing images with the MobiView application, potentially affecting image interpretation.
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: This is an FDA Class II recall involving a risk-of-harm medical device. The potential for alignment errors in image analysis could affect diagnostic accuracy, but no injuries or illnesses have been reported, meeting the rubric criterion for Score 3.
Plain-English summary
Philips North America LLC is recalling certain Ingenia 1.5T magnetic resonance imaging (MRI) systems due to a potential for alignment errors in the cross-reference line functionality when reviewing images generated with the MobiView application.
The alignment errors could affect the accuracy of image interpretation by medical professionals. The affected systems include 264 units distributed worldwide, with 46 units in the United States. Six model numbers are involved in this recall: 781315, 781341, 781396, 782101, 782115, and 782140.
The recalled product
- Product
- Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
- 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 Numbers: (1) 781315
- (2) 781341
- (3) 781396
- (4) 782101
- (5) 782115
- (6) 782140
- UDI-DI: (1) 00884838099715
- (2) 00884838055322
- (3) 00884838009820
- (4) 00884838098275
- (5) 00884838099043
- (6) 00884838108646
- Serial Numbers: (1) 61003
- 61005
- 61007
- 61014
- 61022
- 61023
- 61024
- 61029
Distribution
Distributed nationwide across the United States.
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