Ingenia 1.5T MRI Systems Recalled for Alignment Errors
Philips is recalling Ingenia 1.5T MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images 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 with no reported illnesses or injuries. The hazard is a software/display alignment issue in image review functionality that could impact diagnostic accuracy, but the source text does not indicate harm has occurred.
Plain-English summary
Philips North America LLC is recalling certain Ingenia 1.5T MRI systems (Model Numbers 781315, 781341, 781396, 782101, 782115, and 782140) due to a potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
A total of 264 units have been distributed worldwide, including 46 units in the United States and 218 units outside the United States. The affected systems are identified by specific serial numbers documented by the manufacturer.
Users of affected systems should contact Philips for guidance. Healthcare facilities should verify whether their installed systems match the recalled models and serial numbers and follow manufacturer instructions for remediation.
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
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.
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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