Agency classClass IIOur severity:Severe FDA (Devices)·Z-1930-2025·Announced 2025-06-18

Philips Intera 1.5T Achieva Nova MRI Systems Gradient Coil Fire Risk

Philips is recalling certain Intera 1.5T Achieva Nova MRI systems due to a gradient coil component that can overheat, potentially causing smoke or fire with risk of burns, smoke inhalation, or asphyxia.

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: This is an FDA Class II recall of a medical device where the hazard explicitly includes potential for serious injury (burns, asphyxia) and death. Although no illnesses have been reported, the source text identifies death as a potential risk, which under the severity rubric warrants a Severe classification for Class II recalls with injury/death potential.

Plain-English summary

Philips North America is recalling specific units of the Intera 1.5T Achieva Nova MRI system (Product Number 781172). A component failure in the gradient coil of affected systems can act as a heat source and potentially produce smoke and/or fire.

If smoke or fire occurs, patients and operators may be exposed to smoke inhalation, burns, and asphyxia, which could result in injury or death. The issue could also cause property damage.

Affected units are identified by the following serial numbers: 21218, 21217, 21216, 21289, 21349, 12146, 12063, 12086, 20069, 21027, 21198, 12099, 18641, 21476, 18623, and 12078. A total of 16 units have been identified worldwide, including 1 unit in the United States distributed across AZ, CA, DE, MA, MI, NE, NY, and SD.

Facilities with affected systems should contact Philips immediately regarding repair or replacement options.

The recalled product

Product: Intera 1.5T Achieva Nova Product Number: 781172;
Manufacturer: Philips North America
Category: Medical Device — MRI Equipment
Hazard: fire
burn-injury
smoke-inhalation
asphyxia

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 (18)

Product Number: 781172
UDI-DI: no UDI
Serial Numbers: 21218
21217
21216
21289
21349
12146
12063
12086
20069
21027
21198
12099
18641
21476
18623
12078

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Part of a larger recall action

This product is one of 9 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 9 products in this recall →

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Same hazard · fire