Philips SmartPath medical imaging device recalled for alignment errors
Philips is recalling SmartPath to dStream 3.0T medical imaging devices due to potential alignment errors in cross-reference line functionality that could affect image interpretation.
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: FDA Class II recall affecting medical imaging device image review functionality. Although no reported patient harm has occurred, alignment errors in image cross-reference lines could affect diagnostic accuracy. This device falls under risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips North America LLC is recalling the SmartPath to dStream XR and 3.0T medical imaging devices (model numbers 781270 and 782113) due to potential alignment errors in the cross-reference line functionality. When reviewing images generated with the MobiView application, these alignment errors could affect the accuracy of image interpretation.
The recall involves 55 units total: 2 distributed in the United States and 53 distributed internationally across multiple countries worldwide.
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
- Category
- Medical Device — Medical Imaging
- Hazard
- alignment-error
- image-interpretation
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.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03