Agency classClass IIOur severity:High FDA (Devices)·Z-1839-2024·Announced 2024-05-29

Philips Achieva 3.0T MRI System Recall: Fire Hazard Risk

Philips recalls 386 Achieva 3.0T MRI systems due to a loose terminal connection that may create a hotspot and cause smoke or fire in the equipment room.

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: This is an FDA Class II recall concerning a potential fire hazard from a loose electrical connection. The source describes a risk of harm (fire and smoke generation) where equipment operates. With no reported injuries or incidents documented in the source material, the recall qualifies as a risk-of-harm product where injury has not yet been reported, scoring as High (3).

Plain-English summary

Philips North America LLC is recalling 386 units of the Achieva 3.0T MRI system due to a potential fire hazard. The affected equipment includes five model numbers (781345, 781344, 781278, 781277, and 781177) and has been distributed worldwide, including throughout the United States and multiple countries across Europe, Asia, and other regions.

The hazard involves the g-MDU (global Mains Distribution Unit) L3 terminal connection in these systems. The connection may become loose, creating an electrical hotspot that may cause smoke or fire to develop in the equipment's technical room. This poses a fire safety risk in healthcare facilities operating the affected systems.

A complete list of affected serial numbers has been provided to the FDA by the manufacturer.

The recalled product

Product: Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177
Manufacturer: Philips North America Llc
Category: Medical Device — MRI System
Hazard: fire
electrical-hazard
Affected units: 386

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 (4)

UDI-DI: (1) 781345 N/A
(2) 781344 N/A
(3) 781278 (01)00884838004139(21)
(4) 781277 N/A

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 30 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 30 products in this recall →

Same manufacturer · Philips North America Llc

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Same hazard · fire