MRI Tabletop Movement Malfunction in Manual Mode Affects Philips Ingenia Systems
Philips Ingenia 1.5T CX-a MRI systems may have a tabletop that fails to fully move in or out during manual operation, 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 an FDA Class II recall involving a risk-of-harm scenario where a mechanical malfunction could delay patient evacuation and treatment. No illnesses, injuries, or deaths have been reported. The recall meets the rubric criterion for High severity: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Philips North America LLC is recalling certain Ingenia 1.5T CX-a Magnetic Resonance (MRI) systems, models 781261 and 781262. These systems are diagnostic medical devices used to produce detailed images of the head, body, and extremities.
In manual mode, the patient tabletop may not completely move in or out of the MRI bore. This malfunction could delay patient evacuation and result in delayed treatment.
The affected devices were distributed worldwide, including throughout the United States. A total of 12 units of model 781261 and 137 units of model 781262 are included in this recall.
This is a Class II recall issued by the FDA.
The recalled product
- Product
- Ingenia 1.5T 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:
- Manufacturer
- Philips North America Llc
- Hazard
- mechanical-failure
- evacuation-delay
- treatment-delay
Distribution
Distributed nationwide across the United States.
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