Agency classClass IIOur severity:High FDA (Devices)·Z-0392-2024·Announced 2023-11-29

MRI Machine Gradient Coil Potential Failure Could Produce Smoke and Fire

Philips Ingenia 1.5T CX MRI systems may experience gradient coil failure that could produce smoke and/or fire. The FDA has classified this as a Class II recall affecting 48 units distributed nationwide and internationally.

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 involving medical diagnostic equipment with potential fire and smoke hazard from component failure. No illnesses or injuries have been reported; the hazard remains theoretical. This risk-of-harm scenario warrants a High severity classification.

Plain-English summary

Philips North America LLC is recalling the Ingenia 1.5T CX magnetic resonance imaging (MRI) system due to a potential component failure. The gradient coil in affected units may fail, producing smoke and/or fire.

The recall affects 48 units of this diagnostic imaging equipment classified as FDA Class II. The systems have been distributed nationwide in the United States and to facilities in more than 40 countries worldwide.

Facilities operating affected systems should verify if their equipment matches the recalled product numbers and serial numbers listed in the FDA's official recall notice. Healthcare providers should contact Philips North America LLC with questions or to discuss potential mitigation measures.

The recalled product

Product: Ingenia 1.5T CX
Manufacturer: Philips North America Llc
Category: Medical Device — Diagnostic Imaging / MRI
Hazard: fire
smoke
equipment-failure
Affected units: 48

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)

Product No. 781261 & 781262
UDI-DI: (01)00884838068438(21)77008
(01)00884838068438(21)77016
(01)00884838068438(21)77018
(01)00884838068445(21)77032
(01)00884838068445(21)77034
(01)00884838068445(21)77035
(01)00884838068445(21)77038
(01)00884838068445(21)77040
(01)00884838068445(21)77041
(01)00884838068445(21)77046
(01)00884838068445(21)77049
(01)00884838068445(21)77050
(01)00884838068445(21)77054
(01)00884838068445(21)77056
(01)00884838068445(21)77058
(01)00884838068445(21)77059
(01)00884838068445(21)77061
(01)00884838068445(21)77062
(01)00884838068445(21)77065

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 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 7 products in this recall →

Same manufacturer · Philips North America Llc

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Same hazard · fire