MRI Diagnostic Device Screws May Loosen, Block Tabletop
Philips SmartPath to dStream 1.5T MRI devices may have loose assembly screws that could block the diagnostic tabletop and delay imaging. 32 units distributed worldwide.
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: Class II recall involving risk-of-harm equipment failure with no reported illnesses or injuries. Per the rubric, products with theoretical hazards but no actual harm reported score at most 3 (High).
Plain-English summary
Philips North America LLC is recalling 32 units of the SmartPath to dStream for 1.5T MRI diagnostic device, used to obtain cross-sectional and spectroscopic images of the head, body, or extremities.
The integrated radio frequency (IRF) carrier assembly contains screws that may come loose and protrude beyond the surface. If loosened, these screws could interfere with other moving parts and potentially block the horizontal tabletop.
A blocked tabletop may delay diagnosis and cause patient anxiety if a patient remains on the tabletop inside the bore longer than anticipated. The affected units have been distributed worldwide, including throughout the US and to more than 50 countries.
The recalled product
- Product
- SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782112; 2) 781260
- Manufacturer
- Philips North America Llc
- Affected units
- 32
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 (2)
- Model UDI-DI: 782112 (01)00884838098886(21)
- 781260 (01)00884838095076(21). Serial Numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 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 13 products in this recall →Related recalls
Same manufacturer · Philips North America Llc
See all →- HighPhilips Recalls IQon Spectral CT Systems Due to Radiation Issue
FDA (Devices) · 2026-09-09
- HighPhilips CT Systems Recalled for Unintended Radiation Performance Issues
FDA (Devices) · 2026-09-09
- HighPhilips Brilliance CT Systems Recalled for Unintended Radiation Issue
FDA (Devices) · 2026-09-09
- HighPhilips CT Systems Recalled for Unintended Radiation Performance Issues
FDA (Devices) · 2026-09-09
- HighPhilips Recalls Cardiac Workstation 5000 Units for Inaccurate Heart Rate Data
FDA (Devices) · 2026-08-26
Same hazard · mechanical failure
See all →- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighForest River Transit Buses Recalled for Wheelchair Lift Control Failure
NHTSA · 2026-09-01
- HighBlue Bird Recalls Vision School Buses Due to Wheelchair Lift Defect
NHTSA · 2026-08-31
- SevereMagic Tilt Watercraft Trailers Recalled Due to Winch Weld Failure
NHTSA · 2026-08-28