The Recall Desk
HighFDA (Devices)·Z-0914-2019·Announced 2019-03-06

Philips Achieva 3.0T TX MRI Systems Recalled for Falling Speaker Hazard

Philips is recalling 11,226 Achieva 3.0T TX 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 (falling objects in a clinical setting) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

Philips Medical Systems Nederlands is recalling 11,226 Achieva 3.0T TX Nuclear Magnetic Resonance Imaging (MRI) systems, Model Number 781345. The recall covers all systems distributed nationwide in the United States.

The recall is being issued 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 presents a risk of injury to patients or staff in the vicinity of the equipment.

Healthcare facilities that have these systems should contact Philips Medical Systems Nederlands for instructions on how to address the issue. Consumers and patients should not use the affected MRI systems until the manufacturer provides guidance on the necessary corrective actions.

The recalled product

Product
Achieva 3.0T TX, Model Number 781345. Nuclear Magnetic Resonance Imaging System
Manufacturer
Philips Medical Systems Nederlands
Category
Medical Device — MRI Systems
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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