Agency classClass IIOur severity:High FDA (Devices)·Z-1850-2024·Announced 2024-05-29

Philips Ingenia Ambition S MRI systems recalled for potential fire hazard

Philips is recalling Ingenia Ambition S MRI systems due to a potential fire hazard. A loose terminal connection in the electrical distribution unit may create a hotspot and smoke or fire in hospital technical rooms.

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 involving a risk-of-harm product (potential fire hazard) where no injuries, fires, or property damage have been reported. The hazard is potential rather than realized.

Plain-English summary

Philips North America LLC is recalling 328 Ingenia Ambition S magnetic resonance imaging (MRI) systems with model numbers REF 782139, 782133, 782108, and 781359. Specific serial numbers are identified in the recall documentation.

The recall addresses a potential fire hazard involving the global Mains Distribution Unit (g-MDU) L3 terminal connection. This connection may become loose, creating a hotspot that could result in smoke or fire in the hospital's technical room.

Affected systems were distributed worldwide, including throughout the United States and internationally to Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, and the United Kingdom.

Healthcare facilities with these MRI systems should contact Philips North America LLC immediately for guidance on inspection and remediation of the affected terminal connections. The FDA has classified this as a Class II recall.

The recalled product

Product: Ingenia Ambition S Model Number (REF): (1) 782139; (2) 782133; (3) 782108; (4) 781359
Manufacturer: Philips North America Llc
Category: Medical Device — Magnetic Resonance Imaging (MRI) System
Hazard: fire
electrical-hazard
overheating
Affected units: 328

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 (3)

UDI-DI: (1) 782139 (01)00884838108639(21)
(2) 782133 N/A
(3) 782108 (01)00884838098343(21)

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 →

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Same hazard · fire