MRI Diagnostic Device Loose Screws May Block Patient Tabletop
Philips SmartPath dStream MRI devices have loose screws in the RF carrier assembly that may interfere with the moving tabletop, potentially delaying diagnosis. Affected units should be inspected and repaired immediately.
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: FDA Class II recall with no reported hospitalizations, injuries, or deaths. The hazard (loose screws potentially interfering with equipment operation) presents a risk of harm but no actual injuries have been documented, fitting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Philips North America is recalling SmartPath to dStream for XR and 3.0T MRI diagnostic devices, which are used to obtain cross-sectional images of the head, body, or extremities. The recall affects 14 units distributed worldwide, including across the United States and numerous international markets.
The integrated radio frequency (IRF) carrier assembly screws may come loose and protrude beyond the device surface. If loose, these screws could interfere with other moving parts, potentially blocking the horizontal tabletop. This defect may result in diagnostic delays and increased patient anxiety if a patient is left inside the scanner longer than anticipated.
Healthcare facilities and medical imaging centers using affected units have been identified based on the device's UDI-DI number and serial numbers. The 14 recalled units span worldwide distribution including the United States, Argentina, Australia, Belgium, Brazil, Canada, and numerous other countries.
Healthcare providers should immediately cease use of affected devices and contact Philips North America for inspection and repair instructions. Patients should consult their healthcare providers if they have questions about MRI procedures they have already undergone.
The recalled product
- Product
- SmartPath to dStream for XR and 3.0T- 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) 782113; 2) 781270; 3) 782129
- Manufacturer
- Philips North America Llc
- Affected units
- 14
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: 782113 (01)00884838098909(21)
- 781270 (01)00884838095083(21)
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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