Ingenia 3.0T MRI System Software Defect Affecting Image Alignment
Philips Ingenia 3.0T MRI systems may display misaligned cross reference lines in the MobiView image review application, potentially affecting diagnostic accuracy. Firmware updates are required for affected units.
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 with software defect affecting image interpretation accuracy; no injuries or illnesses reported, but poses a risk-of-harm in diagnostic settings.
Plain-English summary
Philips North America is recalling Ingenia 3.0T MRI systems (models 781342, 781377, and 782103) due to a software defect in the MobiView application. The cross reference line functionality used when reviewing MRI images may display with alignment errors, potentially affecting diagnostic accuracy.
The affected units include 193 systems worldwide: 36 in the United States and 157 distributed internationally across more than 50 countries including Canada, the United Kingdom, Australia, and others.
Clinicians using affected systems should be aware of this potential issue when reviewing images with the cross reference line functionality in MobiView. Healthcare facilities with affected Ingenia 3.0T MRI systems should contact Philips for information about firmware updates and corrective actions to resolve this defect.
The recalled product
- Product
- Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;
- Manufacturer
- Philips North America Llc
- Hazard
- software-defect
- image-alignment-error
- diagnostic-inaccuracy
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) 781342
- (2) 781377
- (3) 782103
- UDI-DI: (1) 00884838055339
- (2) 00884838009813
- (3) 00884838098299
- Serial Numbers: (1) 71029
- 71031
- 71038
- 71185
- 71193
- 71319
- 71322
- 71336
- 71355
- 71532
- 71556
- 71739
- 71796
- 85006
Distribution
Distributed nationwide across the United States.
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