MRI Tabletop Movement Failure May Delay Patient Evacuation and Treatment
Philips MRI systems may fail to move the examination tabletop in manual mode, potentially delaying patient evacuation and medical treatment.
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 or injuries. The defect represents a risk-of-harm scenario where equipment malfunction could delay critical patient evacuation and treatment, meeting the High severity criterion for risk-of-harm products without reported injury.
Plain-English summary
Philips SmartPath to dStream for XR and 3.0T-a Magnetic Resonance (MRI) systems are subject to this recall due to a potential mechanical defect. In manual mode, the examination tabletop may not completely move in or out of the scanner bore.
This defect could result in a delay in patient evacuation from the MRI bore, which could subsequently delay necessary medical treatment. The recall affects 198 units distributed worldwide, including throughout the United States and to numerous other countries.
Healthcare facilities with affected MRI systems should be aware of this recall and contact the manufacturer for guidance on addressing the defect.
The recalled product
- Product
- SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or…
- Manufacturer
- Philips North America Llc
- Affected units
- 198
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 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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