The Recall Desk
HighFDA (Devices)·Z-2412-2021·Announced 2021-09-15

Philips Ingenia 1.5T MRI tabletop malfunction may delay patient evacuation

Philips is recalling 42 Ingenia 1.5T MRI systems because the tabletop may not fully move in or out in manual mode, potentially delaying patient evacuation and 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: This is a risk-of-harm product where the hazard (potential treatment delay due to inability to evacuate the patient) is explicitly theoretical with no reported injuries or illnesses. The source text contains no evidence of actual harm, limiting the severity to 3 per the rubric.

Plain-English summary

Philips North America LLC is recalling 42 Ingenia 1.5T Evolution-a Magnetic Resonance (MRI) systems, Model 781315, due to a malfunction that may occur when the device is operated in manual mode.

The tabletop (patient bed) may not completely move into or out of the MRI bore when manual mode is used. This could result in delayed patient evacuation from the bore and delayed treatment. The FDA classified this as a Class II recall.

The affected devices have been distributed worldwide, including throughout the United States and in numerous other countries. Affected serial numbers are identified in the FDA's recall notice.

The recalled product

Product
Ingenia 1.5T Evolution-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 Mod
Manufacturer
Philips North America Llc
Category
Medical Device — Medical Imaging / MRI System
Hazard
  • mechanical-malfunction
  • patient-evacuation-delay
  • treatment-delay

Distribution

Distributed nationwide across the United States.

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