The Recall Desk
HighFDA (Devices)·Z-1590-2024·Announced 2024-04-24

MRI system patient support table floor plate installation defect

Philips MRI systems may have an incorrectly installed patient support table floor plate, creating a potential stability risk during patient imaging.

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 a Class II recall involving a structural installation defect on critical patient-support equipment that creates risk of patient harm through potential loss of table stability. No injuries or illnesses have been reported, meeting the rubric criterion: 'risk-of-harm products where injury has not yet been reported' = High.

Plain-English summary

This recall affects 41 units of the SmartPath to dStream for XR and 3.0T Magnetic Resonance System manufactured by Philips North America LLC.

The patient support table floor plate may be incorrectly installed, which could compromise the stability and safety of the patient support table during use. This is a Class II recall.

Affected units have been distributed worldwide, including throughout the United States and over 100 additional countries. Specific affected model numbers, UDI-DI codes, and serial numbers are available through the FDA recall notice.

Healthcare facilities operating affected MRI systems should contact Philips North America LLC to verify proper floor plate installation and obtain corrective action instructions.

The recalled product

Product
SmartPath to dStream for XR and 3.0T, Magnetic Resonance System.
Manufacturer
Philips North America Llc
Hazard
  • installation-defect
  • structural-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 (20)

  • Model No. 781270
  • 782113
  • 782129
  • UDI-DI 884838098909
  • 884838105805
  • Serial No. 17271
  • 38281
  • 17560
  • 17252
  • 34202
  • 34153
  • 34127
  • 38311
  • 34128
  • 34172
  • 17470
  • 34131
  • 24021
  • 24093
  • 17258

Distribution

Distributed nationwide across the United States.