Ingenia 3.0T MRI Systems Recalled for Image Alignment Errors
Philips is recalling certain Ingenia 3.0T MRI systems worldwide due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This is an FDA Class II recall of a medical device with a software/functionality issue. No illnesses, injuries, or deaths have been reported. The hazard is a potential alignment error in image review tools, which represents a functionality issue rather than an immediate patient safety threat, placing it in the Moderate category.
Plain-English summary
Philips North America LLC is recalling 193 units of the Ingenia 3.0T MRI system (Model Numbers 781342, 781377, and 782103) distributed worldwide. The recall affects 36 units in the United States and 157 units outside the US across multiple countries.
The recalled systems may experience alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. This could result in misalignment of reference lines used during image review.
Affected healthcare facilities and clinicians should contact Philips for instructions regarding the remedy. Patients who have undergone imaging with these systems should consult their healthcare provider if they have concerns about image quality or diagnostic accuracy.
The recalled product
- Product
- Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;
- 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) 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.
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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