Agency classClass IIOur severity:High FDA (Devices)·Z-2202-2025·Announced 2025-08-06

Philips Evolution Upgrade 1.5T gradient coils may act as a heat source

Evolution Upgrade 1.5T MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 93 units are affected.

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: Risk-of-harm product: a component that may produce smoke or fire in a scanner enclosing a patient, with no injury reported in the source.

Plain-English summary

The Evolution Upgrade 1.5T MR system, model numbers 782116 and 782148, UDI-DI 00884838099722 and 00884838108714, is being recalled. The action covers 93 units, identified by the serial numbers in the recall notice.

The stated reason is the potential for component failures in the gradient coil of the affected MR systems, which may act as a heat source with a potential to produce smoke and/or fire. The FDA classified the action as Class II. The source does not report any injury having occurred.

Distribution was worldwide, including nationwide in the United States and to Albania, Algeria and Angola among other markets. The systems are installed in healthcare facilities rather than sold to consumers.

Facilities should identify affected systems using the model numbers, UDI-DI codes and serial numbers above and follow the instructions issued by the manufacturer.

The recalled product

Product: Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;
Manufacturer: Philips North America
Category: Medical Device — MRI system
Hazard: gradient-coil
overheating
fire-hazard
smoke
class-ii
Affected units: 93

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 Numbers (REF): (1) 782116
(2) 782148
UDI-DI: (1) 00884838099722
(2) 00884838108714
Serial Numbers: (1) 41017
41024
41025
41041
41042
41047
41051
41080
41089
41130
41139
41143
41144
41179
41189
41196

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 19 recalled by Philips North America 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 19 products in this recall →

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Same hazard · gradient coil