The Recall Desk
ModerateFDA (Devices)·Z-2398-2023·Announced 2023-08-16

Philips Ingenia Elition X MR Systems Diagnostic Cable Installation Issue

Philips is recalling 601 Ingenia Elition X MR systems because a diagnostic cable may not have been properly installed, though system operation is not affected.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II FDA recall affecting only service diagnostic functionality. No illnesses or injuries have been reported, and the issue does not impact patient safety or system operation.

Plain-English summary

Philips North America is recalling 601 Ingenia Elition X Magnetic Resonance (MR) systems, which are medical imaging devices used in healthcare settings. The systems are identified by product numbers 781358, 782107, and 782118, with units distributed nationwide in the US and globally.

During installation of the SmokeDetector Interlock component, a connecting cable between the SmokeDetector Interlock and the host PC may not have been properly installed. This cable is used exclusively for service diagnostics and does not affect the functionality of the MR system or its SmokeDetector Interlock.

Healthcare facilities operating affected systems should contact Philips North America to arrange verification of proper cable installation. While the diagnostic cable issue does not impact clinical operation of the MR system, Philips recommends ensuring proper installation to maintain service diagnostic capabilities.

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 — MR Imaging System
Hazard
Affected units
601

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 (5)

  • Product Number 781358: UDI-DI: 00884838088115
  • Product Number 782107: UDI-DI: 00884838098336
  • Product Number 782118
  • UDI-DI: 00884838099746
  • Serial Numbers: 85661 71060 42054 42085 42113 42306 42329 71019 71025

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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Same hazard · installation defect

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