The Recall Desk
SevereFDA (Devices)·Z-0884-2019·Announced 2019-03-06

Philips Achieva XR MRI Systems Recalled for Ceiling Speaker Hazard

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

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The hazard involves a heavy object falling and being pulled by a strong magnetic field, which constitutes a significant injury or property-damage risk, aligning with the 'Severe' criteria for structural or significant injury risks.

Plain-English summary

Philips Medical Systems Nederlands is recalling 11,226 Achieva XR 1.5T/3.0T Nuclear Magnetic Resonance Imaging Systems (Model Number 781153). The recall covers all systems distributed nationwide in the United States.

The recall is issued because there is a potential for the ceiling speakers to fall from their position and be pulled to the MR system by the magnetic field. This presents a risk of injury or property damage if the speakers detach and are attracted to the magnet.

Healthcare facilities that have these systems should contact Philips Medical Systems Nederlands for instructions on how to address the issue. The source text does not specify a deadline or specific remediation steps beyond the recall notification.

The recalled product

Product
Achieva XR 1.5T/3.0T, Model Number 781153. Nuclear Magnetic Resonance Imaging System
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 →

Same manufacturer · Philips Medical Systems Nederlands

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