The Recall Desk
HighFDA (Devices)·Z-1576-2024·Announced 2024-04-24

MRI System Patient Support Table Floor Plate May Be Incorrectly Installed

Philips has recalled 2 Intera 1.5T MRI systems due to potential incorrect installation of the patient support table floor plate.

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 medical device recall involving a physical installation defect that poses a potential safety hazard. No illnesses or injuries have been reported. Per the severity rubric, this qualifies as 'High' as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Philips North America LLC is recalling 2 units of the Intera 1.5T Achieva IT Nova Magnetic Resonance System (Model No. 781175, serial numbers 15002 and 15003). The patient support table floor plate may be incorrectly installed on these units.

An incorrectly installed floor plate poses a potential safety hazard that could affect the safe operation and use of the equipment.

The affected units were distributed worldwide, including throughout the United States and to numerous countries. Healthcare facilities that have received these units should contact Philips North America LLC regarding inspection and correction of the installation.

The recalled product

Product
Intera 1.5T Achieva IT Nova, Magnetic Resonance System.
Manufacturer
Philips North America Llc
Category
Medical Device — Magnetic Resonance Imaging
Hazard
  • installation-defect
  • fall-hazard

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 (4)

  • Model No. 781175
  • UDI-DI n/a
  • Serial No. 15002
  • 15003.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category