MRI Diagnostic Device Recalls Due to Loose Screw Assembly Risk
Philips recalls Evolution Upgrade 3.0T MRI devices due to loose screws that may block the tabletop and delay diagnosis. Devices with the affected serial numbers should be taken out of service.
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 Class II recall of diagnostic imaging equipment where loose screws could block the tabletop and delay diagnosis, posing a risk to patient care. No injuries or illnesses have been reported.
Plain-English summary
Philips North America LLC is recalling the Evolution Upgrade 3.0T, a magnetic resonance imaging (MRI) diagnostic device used to obtain cross-sectional images and spectroscopic data of the head, body, or extremities. Three units with REF numbers 782117 and 782143 are affected, with serial numbers 85675, 85687, and 85695.
The integrated radio frequency (IRF) carrier assembly contains screws that may come loose and protrude beyond the surface. When this occurs, the loose screws can interfere with other moving parts, potentially blocking the horizontal tabletop from moving properly.
If the tabletop becomes blocked, diagnostic imaging procedures may be delayed. Patients could experience anxiety from remaining inside the MRI bore longer than expected while the mechanical issue is identified and resolved.
Affected facilities that operate these devices should inspect their units immediately and verify serial numbers against the recall notice. If your facility has one of the three affected units, do not operate it until the screws have been properly secured or the device has been serviced by Philips.
The recalled product
- Product
- Evolution Upgrade 3.0T - 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: (1) 782117 (2) 782143
- Manufacturer
- Philips North America Llc
- Affected units
- 3
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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