MRI diagnostic device screws may loosen and block tabletop
Philips is recalling the Ingenia Elition X MRI device due to loose screws in the RF carrier assembly that could block the tabletop and delay diagnosis or cause patient anxiety.
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: FDA Class II medical device with mechanical defect that poses a risk to patient care through potential diagnostic delays and extended patient exposure time in the MRI bore. No injuries have been reported. This meets the criterion for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Philips is recalling the SmartPath to Ingenia Elition X magnetic resonance imaging (MRI) diagnostic device due to a defect in the Integrated Radio Frequency (IRF) Carrier assembly. Screws in this assembly may come loose and protrude beyond the surface.
If the screws protrude, they could interfere with other moving parts of the device and potentially block the horizontal tabletop. This could prevent the tabletop from moving properly, leaving a patient positioned inside the MRI bore for a longer duration than anticipated. This may lead to diagnostic delays and patient anxiety from the extended time in the device.
Two units of the SmartPath to Ingenia Elition X with REF number 782118 are affected. The affected serial numbers are 85661 and 85676. These devices have been distributed worldwide, including throughout the United States and more than 40 countries.
The recalled product
- Product
- SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782118
- Manufacturer
- Philips North America Llc
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: (01)00884838099746(21) Serial Numbers: 85661 85676
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 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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