SmartPath to Ingenia Elition X MRI Systems Alignment Error Recall
Philips is recalling SmartPath to Ingenia Elition X MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. The alignment errors could affect image interpretation.
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 3/5 (High).
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 affecting medical imaging devices where alignment errors could compromise diagnostic accuracy. Although no reported illnesses or injuries are stated in the source, the potential for misinterpretation of medical images represents a risk of harm to patients who rely on accurate image analysis.
Plain-English summary
Philips North America LLC is recalling SmartPath to Ingenia Elition X medical imaging systems. The recall affects Model Numbers 782118 and 782144, with 16 units distributed worldwide including the US and numerous international markets.
The devices have a potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. These alignment errors could potentially affect the accuracy of image interpretation by clinicians.
The affected serial numbers are: for Model 782118—42072, 42194, 42306, 71019, 71025, 71050, 85661, 85676; for Model 782144—42062, 42105, 42323, 42346, 42441, 71278, 71504, 71508. Healthcare providers who have received these devices should contact Philips North America LLC for instructions on obtaining a software update or other remedial measures.
The recalled product
- Product
- Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;
- Manufacturer
- Philips North America Llc
- Affected units
- 16
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) 782118
- (2) 782144
- UDI-DI: (1) 00884838099746
- (2) 00884838108677
- Serial Numbers: (1) 42072
- 42194
- 42306
- 71019
- 71025
- 71050
- 85661
- 85676
- (2) 42062
- 42105
- 42323
- 42346
- 42441
- 71278
- 71504
- 71508
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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