The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2395-2023·Announced 2023-08-16

MR Imaging System Smoke Detector Interlock Vulnerable to Bypass via Power Cycling

Philips Ingenia Elition X MR systems can have their smoke detection safety interlock bypassed by power cycling the equipment. This vulnerability could allow unsafe operation during hazardous conditions.

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 device recall involving a medical device with a bypassed safety mechanism. Although no injuries or hospitalizations have been reported, the vulnerability creates a potential fire and operational risk. Per the rubric, risk-of-harm products where injury has not yet been reported score as High.

Plain-English summary

Philips North America is recalling the Ingenia Elition X Magnetic Resonance (MR) system (Product Numbers 781358, 782107, and 782118). The recall affects 640 units distributed nationwide and globally. The devices include a smoke detection interlock system designed to lock the equipment when smoke is detected to prevent operation during hazardous conditions.

A safety vulnerability has been identified: system operators can bypass the smoke detector interlock mechanism by power cycling the equipment. This allows the system to resume operation after a smoke detection event without the intended safety lockout.

The vulnerability could allow the equipment to operate in conditions where the smoke detector has triggered, potentially exposing patients and operators to fire or other hazards. Affected facilities should contact Philips North America for mitigation guidance. Operators should not power cycle the equipment to override smoke detection and should follow proper safety protocols when smoke detection occurs.

The recalled product

Product
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
Manufacturer
Philips North America
Category
Medical Device — MRI/Diagnostic Imaging System
Hazard
Affected units
640

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 (9)

  • Product Number 781358: UDI-DI: 00884838088115
  • Product Number 782107: UDI-DI: 00884838098336
  • Product Number 782118
  • Product Number 782119: UDI-DI: 00884838104129
  • Serial Numbers: 66001 66002
  • Product Number 782136: UDI-DI: 00884838108608
  • Serial Numbers: 28509
  • Product Number 782151: UDI-DI: N/A
  • Serial Numbers: 26501

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

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