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.
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: 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.
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