The Recall Desk
ModerateFDA (Devices)·Z-2399-2023·Announced 2023-08-16

MRI System Cable Installation Issue During Service Setup

Philips Ingenia Elition S MR systems may have an improperly installed cable connecting the SmokeDetector Interlock to the host PC. This affects service diagnostics only and does not impact system functionality.

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 an FDA Class II recall of an installation procedure issue that does not affect system functionality. No illnesses, injuries, or safety incidents have been reported. The defective cable affects service diagnostics only, making this a voluntary precautionary recall.

Plain-English summary

Philips North America is recalling Ingenia Elition S Magnetic Resonance (MR) systems with Product Numbers 781357 and 782106. During installation of the SmokeDetector Interlock system, a connecting cable between the interlock and host PC may not have been properly installed.

The affected cable is used only for service diagnostics and does not impact the normal operation of the MR system or the SmokeDetector Interlock functionality. The recall affects approximately 601 systems distributed nationwide and globally.

Facilities using affected systems should verify the cable connection during the next service visit or contact Philips North America for installation verification. No injuries or safety incidents have been reported.

The recalled product

Product
Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
Manufacturer
Philips North America
Category
Medical Device — Diagnostic Imaging Equipment
Hazard
  • installation-defect
  • service-diagnostics-issue

Distribution

Distributed nationwide across the United States.

Related recalls

Same category