Philips MRI System Gradient Coil May Produce Smoke or Fire
Philips is recalling certain Ingenia Elition S MR Systems due to a potential fire or smoke hazard from the gradient coil. The affected units are distributed nationwide in the United States.
What this means for you
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 recall involving a potential fire and smoke hazard from the gradient coil. No incidents, injuries, or deaths are reported in the source text. Per the severity rubric, risk-of-harm products without reported injury score as High (3).
Plain-English summary
Philips North America LLC is recalling 566 Ingenia Elition S MR Systems distributed nationwide in the United States. The recall involves three model numbers: 781357, 782106, and 782137.
The gradient coil in these MRI systems may act as a heat source with the potential to produce smoke and/or fire.
Healthcare facilities using these systems should verify whether any recalled units are present by checking the model numbers and serial numbers against information provided by the manufacturer. Philips North America LLC will provide additional information and support regarding this recall.
The recalled product
- Product
- Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — MRI System
- Hazard
- fire
- smoke
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 (6)
- Model 781357: UDI-DI: 00884838088108
- Serial Numbers: 46002 46014 46025 46065 46077 46088 46097 46109 46071
- Model 782106: UDI-DI: 00884838098329
- Serial Numbers: 46224 46225 46265 46269 46311
- Model Number 782137: UDI-DI: 00884838108615
- Serial Numbers: Included in Letter but No Devices Distributed in the US.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereDa Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01
- SevereMedline angiography and radiology convenience kits recalled for unapproved design changes
FDA (Devices) · 2026-07-01
- ModerateOctopus Evolution AS Tissue Stabilizer Model TS2500 Tubing Assembly Issue Recall
FDA (Devices) · 2026-07-01
- ModerateOctopus 4 Tissue Stabilizer incorrectly assembled tubing positions
FDA (Devices) · 2026-07-01
- SevereMedical Device Surgical Kits with Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01