Philips Ingenia MRI System Recalled Due to Ceiling Speaker Hazard
Philips is recalling Ingenia 1.5T CX MRI systems because ceiling speakers may be pulled by the magnetic field and fall.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (falling speakers) that poses a significant injury risk, meeting the criteria for a Severe rating.
Plain-English summary
Philips Medical Systems Nederlands is recalling Ingenia 1.5T CX Nuclear Magnetic Resonance Imaging Systems (Model Number 781261). The recall involves 11,226 units distributed nationwide in the United States.
The recall is issued because there is a potential for the ceiling speakers to fall from their position and be pulled to the MR system by the magnetic field. This hazard could result in injury to patients or staff.
Healthcare facilities should contact Philips Medical Systems Nederlands for instructions on how to address this issue. Consumers should not use the affected systems until the manufacturer provides guidance.
The recalled product
- Product
- Ingenia 1.5T CX, Model Number 781261. Nuclear Magnetic Resonance Imaging System
- Manufacturer
- Philips Medical Systems Nederlands
- Category
- Medical Device — MRI System
- Affected units
- 11,226
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)
- All systems
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 64 recalled by Philips Medical Systems Nederlands 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 64 products in this recall →Related recalls
Same manufacturer · Philips Medical Systems Nederlands
See all →- HighPhilips Allura Xper System power supplies may fail unexpectedly
FDA (Devices) · 2021-06-30
- ModeratePhilips Recalls Azurion X-ray Systems Due to Software Defect
FDA (Devices) · 2019-08-07
- HighPhilips MR Systems Recalled for Magnet Energization Device Electrical Shock Risk
FDA (Devices) · 2019-05-08
- ModeratePhilips Medical Systems Recalls Foot Switches for Allura Xper Systems
FDA (Devices) · 2019-04-24
- ModeratePhilips Medical Systems Recalls Foot Switches for Imaging Systems
FDA (Devices) · 2019-04-24
Same hazard · falling object
See all →- SevereLithonia Lighting Recalls RSX Luminaires with Adjustable Tilt Arms
CPSC · 2026-10-22
- HighMaquet PowerLED 300 Concealed Lighting System Recalled for Detachment Risk
FDA (Devices) · 2026-09-30
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighFord F-650 SD Recall: Liftgate Platform Deck Pins May Break
NHTSA · 2026-08-20
- SevereTerex Digger Derrick Trucks Recalled for Weld Defect
NHTSA · 2026-08-17
Similar recalls
- HighPhilips Ingenia 1.5T CX MRI Recall for Helium Gas Risk
FDA (Devices) · 2018-04-25
- HighPhilips Ingenia MR Systems Recalled for Fire Risk From Loose Connector
FDA (Devices) · 2024-05-29
- HighPhilips Ingenia 1.5T CX MRI System Patient Support Table Installation Defect
FDA (Devices) · 2024-04-24
- HighPhilips Ingenia 1.5T MRI systems recalled for patient support table installation defect
FDA (Devices) · 2024-04-24
- ModeratePhilips Ingenia 1.5T CX MRI System Alignment Error Potential
FDA (Devices) · 2025-05-28
- HighMRI Machine Gradient Coil Potential Failure Could Produce Smoke and Fire
FDA (Devices) · 2023-11-29