The Recall Desk
HighFDA (Devices)·Z-0929-2019·Announced 2019-03-06

Philips Ingenia 1.5T MRI System Recalled for Falling Speaker Hazard

Philips is recalling 11,226 Ingenia 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

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 risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Philips Medical Systems Nederlands is recalling 11,226 Ingenia 1.5T Linac MRI systems, Model Number 781483, distributed nationwide in the United States. The recall was initiated because there is a potential for the ceiling speakers to fall from their position and be pulled to the MRI system by the magnetic field.

This recall affects all systems of this specific model. The hazard involves the physical movement of the speakers due to the strong magnetic field generated by the MRI machine, which could result in the speakers detaching and moving toward the equipment.

Consumers and healthcare facilities with these systems should contact Philips Medical Systems Nederlands for further instructions on how to address the potential hazard.

The recalled product

Product
NZM101 Ingenia 1.5T Linac, Model Number 781483. Nuclear Magnetic Resonance Imaging System
Manufacturer
Philips Medical Systems Nederlands
Category
Medical Device — MRI System
Hazard
Affected units
11,226

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 (1)

  • All systems

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 64 recalled by Philips Medical Systems Nederlands 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 64 products in this recall →

Related recalls

Same manufacturer · Philips Medical Systems Nederlands

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Same hazard · falling object

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