SmartPath to dStream 3.0T Medical Device Recall for Software Error
Philips is recalling the SmartPath to dStream 3.0T medical device due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. This could affect image interpretation accuracy.
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 medical device recall involving a software functionality error that could affect diagnostic image interpretation. Although no reported injuries or illnesses are stated in the source, the potential for misalignment in image review represents a risk of harm in a diagnostic imaging context, meeting the High threshold.
Plain-English summary
Philips North America LLC is recalling the SmartPath to dStream for 3.0T (Model Number 782145) due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
The alignment errors could impact the accuracy of image review and interpretation, potentially affecting clinical decision-making based on those images.
The recalled device has been distributed worldwide, including in the United States and numerous countries. A total of 12 units were distributed outside the United States. The affected devices have specific serial numbers: 17377, 17385, 34114, 34208, 38118, 38170, 38294, 38313, 38336, 73002, 73004, and 74004.
Healthcare facilities or individuals using this device should contact Philips North America LLC for further guidance on remediation or device status.
The recalled product
- Product
- Product Name: SmartPath to dStream for 3.0T; Model Number: 782145
- Manufacturer
- Philips North America Llc
- Affected units
- 12
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.
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.
See all 18 products in this recall →Related recalls
Same manufacturer · Philips North America Llc
See all →- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- ModeratePhilips Achieva 1.5T MRI Systems Recalled for Software Memory Issue
FDA (Devices) · 2026-09-30
- ModeratePhilips MR 7700 MRI Systems Recalled for Software Issue
FDA (Devices) · 2026-09-30
- ModeratePhilips Ingenia MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
- ModeratePhilips MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
Same hazard · software error
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter AU480 Chemistry Analyzer Software Error Recall
FDA (Devices) · 2026-10-07
- HighBard EnCor EnCompass Breast Biopsy System Software Recall
FDA (Devices) · 2026-10-07
- HighPhilips EPIQ Elite Ultrasound System Recalled for Software Error
FDA (Devices) · 2026-09-30
- HighQuantum Rehab Q6 Edge 3 Powered Wheelchair Controller Recalled for Unexpected Braking
FDA (Devices) · 2026-08-12
Similar recalls
- HighSmartPath dStream 3.0T upgrades recalled over elastography stiffness errors
FDA (Devices) · 2026-02-04
- ModeratePhilips SmartPath dStream 3.0T MRI Scanner Software Parameter Error Recall
FDA (Devices) · 2026-05-06
- ModeratePhilips MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
- HighPhilips Medical Device Recalled for Fire Hazard in Electrical Connection
FDA (Devices) · 2024-05-29
- HighSmartPath dStream upgrades recalled over elastography stiffness value errors
FDA (Devices) · 2026-02-04
- ModeratePhilips SmartPath to dStream MR Elastography Software Parameter Error
FDA (Devices) · 2026-05-06