The Recall Desk
HighFDA (Devices)·Z-2413-2021·Announced 2021-09-15

MRI device tabletop may fail to move completely in manual mode

Philips Ingenia MRI tabletops may fail to move completely in manual mode, potentially delaying patient evacuation. The recall affects 144 units 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: FDA Class II recall with no reported illnesses or injuries. The hazard is mechanical malfunction with potential for patient evacuation delay, qualifying as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Philips North America LLC is recalling 144 units of the Ingenia 1.5T S-a Magnetic Resonance System (Model 78137), a diagnostic imaging device used to create cross-sectional and spectroscopic images of the body.

The patient tabletop in these MRI systems may fail to move completely into or out of the scanner bore when operated in manual mode. This defect could delay patient evacuation from the device and potentially delay treatment.

The affected units have worldwide distribution, including throughout the United States.

Healthcare facilities that operate affected devices should contact Philips North America LLC for instructions on how to address this issue.

The recalled product

Product
Ingenia 1.5T S-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 extremities Model: 7813
Manufacturer
Philips North America Llc
Category
Medical Device — Diagnostic Imaging System
Hazard
  • equipment-malfunction
  • evacuation-delay
  • treatment-delay

Distribution

Distributed nationwide across the United States.

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