The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1584-2024·Announced 2024-04-24

Philips MRI System Patient Support Table Floor Plate Installation Issue

Philips is recalling 9 Intera 3.0T Quasar Dual MRI systems (Model 781150) distributed worldwide. The patient support table floor plate may be incorrectly installed on these units.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 involving a risk-of-harm medical device (patient support during MRI procedures) with no reported illnesses or injuries mentioned in the source. The installation issue poses a potential patient safety risk, meeting the criteria for Score 3 per the rubric.

Plain-English summary

Philips North America LLC is recalling 9 units of the Intera 3.0T Quasar Dual Magnetic Resonance System (Model No. 781150). The affected units are identified by serial numbers: 5729, 10138, 10123, 10746, 10136, 10103, 5714, 10182, and 5704.

The patient support table floor plate on these units may be incorrectly installed. The U.S. Food and Drug Administration has classified this as a Class II recall.

These MRI systems have been distributed worldwide, including throughout the United States and internationally.

The recalled product

Product
Intera 3.0T Quasar Dual, Magnetic Resonance System.
Manufacturer
Philips North America Llc
Category
Medical Device — Diagnostic Imaging
Hazard
Affected units
9

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 (11)

  • Model No. 781150
  • UDI-DI n/a
  • Serial No. 5729
  • 10138
  • 10123
  • 10746
  • 10136
  • 10103
  • 5714
  • 10182
  • 5704.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 41 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 41 products in this recall →

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