Philips Ingenia Elition S MRI systems may have incorrectly installed patient support floor plates
Philips North America is recalling 131 Ingenia Elition S magnetic resonance imaging systems due to incorrect installation of the patient support table floor plates.
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 medical device recall involving a structural installation defect on critical patient support equipment. No injuries, illnesses, or hospitalizations have been reported. Per the severity rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Philips North America LLC is recalling 131 units of the Ingenia Elition S Magnetic Resonance System. The patient support table floor plate on these devices may be incorrectly installed.
The affected systems carry Model Numbers 781357 and 782106 and have been distributed worldwide, including throughout the United States and numerous other countries.
Healthcare facilities with affected equipment should contact Philips North America LLC or the U.S. Food and Drug Administration for guidance on verifying proper installation and any corrective measures needed.
The recalled product
- Product
- Ingenia Elition S, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Affected units
- 131
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 (20)
- Model No. 781357
- 782106
- UDI-DI 884838088108
- 884838098329
- Serial No. 46065
- 46071
- 46077
- 46025
- 46224
- 46005
- 46003
- 46001
- 46008
- 46004
- 46007
- 46032
- 46011
- 46012
- 46013
- 46015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 41 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 41 products in this recall →Related recalls
Same manufacturer · Philips North America Llc
See all →- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- ModeratePhilips Achieva 1.5T MRI Systems Recalled for Software Memory Issue
FDA (Devices) · 2026-09-30
- ModeratePhilips MR 7700 MRI Systems Recalled for Software Issue
FDA (Devices) · 2026-09-30
- ModeratePhilips Ingenia MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
- ModeratePhilips MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
Same hazard · installation defect
See all →- HighRaz shower commode chair seat may be reinstalled without engaging brackets
FDA (Devices) · 2026-03-18
- SevereJeep Wagoneer S liftgate hinge cover may detach from vehicle
NHTSA · 2026-03-12
- SevereIC Bus school bus brake lines may be damaged and leak
NHTSA · 2026-02-26
- SevereJeep Grand Cherokee rear coil springs may detach while driving
NHTSA · 2026-01-29
- Severe
Similar recalls
- ModeratePhilips Ingenia Elition S MRI System Alignment Error Recall
FDA (Devices) · 2025-05-28
- SeverePhilips Ingenia Elition S MRI System Recalled for Falling Speaker Hazard
FDA (Devices) · 2019-03-06
- HighPhilips Ingenia MRI Systems Recalled for Table Movement Safety Issue
FDA (Devices) · 2019-01-16
- HighMRI Magnetic Resonance System Tabletop May Fail to Move in Manual Mode
FDA (Devices) · 2021-09-15
- HighDiagnostic MR imaging system hoisting blocks mechanical defect
FDA (Devices) · 2021-06-16
- HighMRI Diagnostic Device Recalled for Loose Assembly Screws Blocking Equipment
FDA (Devices) · 2024-10-02