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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Philips North America Llc
- Affected units
- 42
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.
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