Agency classClass IIOur severity:High FDA (Devices)·Z-1851-2024·Announced 2024-05-29

Philips Ingenia Ambition X MR systems recalled for loose terminal connection fire hazard

Philips is recalling 509 Ingenia Ambition X MR systems due to loose terminal connections in the g-MDU L3 unit that may create hotspots and cause 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: The recall is for a medical device with potential fire and smoke hazards caused by a loose electrical connection. No injuries or hospitalizations have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).

Plain-English summary

Philips North America LLC is recalling 509 Ingenia Ambition X Magnetic Resonance (MR) systems (Model Numbers 782138, 782109, and 781356). These are diagnostic medical devices used in hospitals.

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

The affected units have been distributed worldwide, including across the United States and in 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 affected units should contact Philips immediately for remediation guidance. The FDA assigned this recall the number Z-1851-2024.

The recalled product

Product: Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782138; (2) 782109; (3) 781356
Manufacturer: Philips North America Llc
Category: Medical Device — Diagnostic Imaging Equipment
Hazard: fire
smoke
electrical-hazard
Affected units: 509

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) 782138 (01)00884838108622(21)
(2) 782109 (01)00884838098350(21)
(3) 781356 (01)00884838090040(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