Philips SmartPath to dStream Medical Imaging Software Alignment Error
Philips is recalling SmartPath to dStream for XR and 3.0T medical imaging software due to potential alignment errors in 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 alignment error that could affect image review accuracy but is not characterized as causing patient harm. Class II recalls without reported adverse events are classified as Moderate per the rubric.
Plain-English summary
Philips North America LLC is recalling the SmartPath to dStream for XR and 3.0T medical imaging software (Model Numbers 781270 and 782113) due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
The recall affects 55 units total: 2 units in the US and 53 units in countries worldwide including Canada, Mexico, Brazil, Japan, South Korea, Australia, and numerous European and Middle Eastern countries.
Affected customers who have received these specific model numbers and serial numbers should contact Philips North America LLC for guidance. Users should be aware of the potential for misalignment when using the cross reference line feature in MobiView to review images.
The recalled product
- Product
- Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113;
- 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) 781270
- (2) 782113
- UDI-DI: (1) 00884838095083
- (2) 00884838098909
- Serial Numbers: (1) 17283
- 17299
- 17321
- 17356
- 17357
- 17369
- 17378
- 17398
- 17416
- 17425
- 17473
- 17490
- 17499
- 17550
- 17564
- 17565
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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