The Recall Desk
HighFDA (Devices)·Z-0899-2019·Announced 2019-03-06

Philips Achieva XR MRI Systems Recalled for Falling Speaker Hazard

Philips is recalling Achieva XR 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 heavy equipment) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Philips Medical Systems Nederlands is recalling 11,226 Achieva XR 1.5T/3.0T Nuclear Magnetic Resonance Imaging Systems (Model Number 781253) in the United States. The recall covers all systems distributed nationwide.

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 should contact Philips Medical Systems Nederlands for instructions on how to address the defect. Consumers and patients should not use the affected systems until the issue is resolved by the manufacturer.

The recalled product

Product
Achieva XR 1.5T/3.0T , Model Number 781253. Nuclear Magnetic Resonance Imaging System
Manufacturer
Philips Medical Systems Nederlands
Category
Medical Device — Imaging Equipment
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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