The Recall Desk
HighFDA (Devices)·Z-1579-2024·Announced 2024-04-24

Philips MRI System Patient Support Table Floor Plate Installation Defect

Philips is recalling 12 Intera 1.5T MRI systems worldwide because the patient support table floor plate may be incorrectly installed. Healthcare facilities should verify proper installation.

What this means for you

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 with no reported injuries or deaths. The hazard involves a potential installation defect—the floor plate may be incorrectly installed—which represents a risk-of-harm scenario but without documented patient injury. Per the severity rubric, this qualifies as High (score 3) as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Philips North America is recalling 12 Intera 1.5T Explorer/Nova Dual Magnetic Resonance Systems distributed worldwide. The recall addresses a potential installation defect involving the patient support table floor plate.

The patient support table floor plate may be incorrectly installed on affected units. An improper installation of this structural component could compromise system safety during patient procedures.

The affected systems carry the following serial numbers: 8918, 10035, 8803, 10037, 9025, 10022, 10638, 10640, 8743, 8651, 10091, and 8690. Owners and users of these MRI systems should contact Philips North America to verify correct installation of the patient support table floor plate.

The recalled product

Product
Intera 1.5T Explorer/Nova Dual, Magnetic Resonance System.
Manufacturer
Philips North America Llc
Hazard
  • installation-defect

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 (14)

  • Model No. 781108
  • UDI-DI n/a
  • Serial No. 8918
  • 10035
  • 8803
  • 10037
  • 9025
  • 10022
  • 10638
  • 10640
  • 8743
  • 8651
  • 10091
  • 8690.

Distribution

Distributed nationwide across the United States.