Philips MRI Systems: Patient support table floor plate installation defect
Philips is recalling 448 Ingenia Elition X MRI systems worldwide due to potentially incorrect installation of the patient support table floor plate, which could compromise structural integrity.
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 recall without reported injuries or illnesses. The installation defect in a structural support component presents a theoretical risk of patient harm from instability, meeting the criterion for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Philips North America LLC is recalling 448 units of the Ingenia Elition X Magnetic Resonance System (MRI) due to a potential installation defect affecting the patient support table floor plate.
The patient support table floor plate may be incorrectly installed in affected units. No injuries or illnesses have been reported to date.
The recalled systems were distributed worldwide, including throughout the United States and in more than 100 countries. Healthcare facilities with affected Ingenia Elition X systems should contact Philips for information regarding inspection and corrective action.
Patients who underwent MRI procedures on affected systems should not be alarmed. For concerns, contact your healthcare provider or the facility where your scan was performed.
The recalled product
- Product
- Ingenia Elition X, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Affected units
- 448
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. 782136
- 781358
- 78217
- 782119
- UDI-DI 884838108622
- 884838098336
- 884838104129
- 884838108608
- Serial No. 45051
- 45423
- 45238
- 45264
- 45194
- 45357
- 45113
- 45322
- 45353
- 45269
- 45252
- 45235
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.
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