The Recall Desk
HighFDA (Devices)·Z-1574-2024·Announced 2024-04-24

MRI patient support table floor plate may be incorrectly installed

Philips Intera 1.0T MRI systems may have patient support table floor plates that are incorrectly installed. The defect poses a potential safety risk to patients. Facilities should verify installation and contact Philips service personnel for inspection.

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: The recall involves a structural defect in patient support equipment that could cause falls or injury, meeting the criterion for risk-of-harm products. No injuries, hospitalizations, or adverse events have been reported, and the defect is correctible through service inspection.

Plain-English summary

Philips North America LLC is recalling 19 Intera 1.0T Power/Pulsar Magnetic Resonance (MRI) systems due to a potential installation defect affecting the patient support table floor plate.

The floor plate may be incorrectly installed, which could pose a safety risk during patient procedures or facility use. The 19 affected units are distributed worldwide, including throughout the United States.

No injuries or adverse events have been reported. Facilities with affected systems should contact Philips North America LLC service personnel to inspect the floor plate installation and make corrections if necessary.

The recalled product

Product
Intera 1.0T Power/Pulsar, Magnetic Resonance System.
Manufacturer
Philips North America Llc
Hazard
  • structural-defect
  • fall-risk

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. 781103
  • UDI-DI n/a
  • Serial No. 7062
  • 7164
  • 7102
  • 7113
  • 7084
  • 10381
  • 7097
  • 10383
  • 10384
  • 10391
  • 7150
  • 7074
  • 7237
  • 7190
  • 7198
  • 10413
  • 10382
  • 7103

Distribution

Distributed nationwide across the United States.