The Recall Desk
HighFDA (Devices)·Z-2421-2021·Announced 2021-09-15

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.

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: 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 ext
Manufacturer
Philips North America Llc
Category
Medical Device — Diagnostic Imaging / MRI
Hazard
  • equipment-malfunction
  • treatment-delay
  • evacuation-delay

Distribution

Distributed nationwide across the United States.

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