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
- Affected units
- 266
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.
See all 12 products in this recall →Related recalls
Same manufacturer · Philips North America Llc
See all →- HighPhilips Recalls IQon Spectral CT Systems Due to Radiation Issue
FDA (Devices) · 2026-09-09
- HighPhilips CT Systems Recalled for Unintended Radiation Performance Issues
FDA (Devices) · 2026-09-09
- HighPhilips Brilliance CT Systems Recalled for Unintended Radiation Issue
FDA (Devices) · 2026-09-09
- HighPhilips CT Systems Recalled for Unintended Radiation Performance Issues
FDA (Devices) · 2026-09-09
- HighPhilips Recalls Cardiac Workstation 5000 Units for Inaccurate Heart Rate Data
FDA (Devices) · 2026-08-26