Medical imaging device alignment error in cross-reference functionality
Philips SmartPath to dStream medical imaging devices may display alignment errors in cross-reference lines when reviewing images with the MobiView application, potentially affecting diagnostic accuracy.
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: This is a Class II medical device recall for a potential (not confirmed) defect in a medical imaging system. With no reported injuries or illnesses documented in the source, and the hazard being preventive in nature, this qualifies as a risk-of-harm product where injury has not yet been reported, matching the Score 3 criterion.
Plain-English summary
Philips North America LLC is recalling the SmartPath to dStream for 3.0T medical imaging system (Model 782145). The recall is due to a potential for alignment errors in the cross-reference line functionality when reviewing images generated with the MobiView application.
The affected devices were distributed worldwide, including the United States and numerous other countries. A total of 12 units outside the United States were identified in this recall. The affected product is identified by Model Number 782145.
Cross-reference lines assist clinicians in identifying and verifying anatomical positioning during image interpretation. Potential alignment errors in this functionality could affect the accuracy of diagnostic analysis, as improperly aligned reference lines might lead to misinterpretation of anatomical position.
Clinicians and healthcare facility administrators should be aware of this potential issue with the cross-reference line feature when using the MobiView application with affected devices.
The recalled product
- Product
- Product Name: SmartPath to dStream for 3.0T; Model Number: 782145
- Manufacturer
- Philips North America Llc
- Hazard
- alignment-error
- diagnostic-error
- software-defect
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 (14)
- Model Number: 782145
- UDI-DI: 00884838095083
- Serial Numbers: 17377
- 17385
- 34114
- 34208
- 38118
- 38170
- 38294
- 38313
- 38336
- 73002
- 73004
- 74004
Distribution
Distributed nationwide across the United States.
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