The Recall Desk
HighFDA (Devices)·Z-2420-2021·Announced 2021-09-15

Medical Device Alert: Philips Ingenia MRI Tabletop Movement Failure

Philips Ingenia 3.0T MRI systems may fail to move the patient tabletop completely in or out, potentially delaying patient evacuation and treatment. 266 units are affected 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. The device malfunction presents a risk of patient evacuation delay and treatment postponement in a medical imaging setting, without reported injuries. This meets the criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips North America LLC is recalling 266 Ingenia 3.0T CX-a Magnetic Resonance (MRI) systems due to a malfunction in the patient tabletop movement mechanism.

When the system is operated in manual mode, the tabletop may not completely move in or out of the MRI bore. This failure could delay patient evacuation from the imaging chamber and postpone necessary treatment.

The affected systems have been distributed worldwide, including throughout the United States. Healthcare facilities using these systems should be aware of this issue.

The recalled product

Product
Ingenia 3.0T CX-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 Models: 7
Manufacturer
Philips North America Llc
Category
Medical Device — Diagnostic Imaging / MRI
Hazard
  • tabletop-movement-failure
  • patient-evacuation-delay
  • treatment-delay

Distribution

Distributed nationwide across the United States.

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