The Recall Desk
HighFDA (Devices)·Z-0928-2019·Announced 2019-03-06

Philips Achieva 3.0T MRI System Recalled for Falling Speaker Hazard

Philips is recalling 11,226 Achieva 3.0T MRI systems because ceiling speakers may fall due to magnetic attraction.

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 speakers) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed harm.

Plain-English summary

Philips Medical Systems Nederlands is recalling 11,226 Achieva 3.0T TX for PET Nuclear Magnetic Resonance Imaging Systems (Model Number 781479) distributed nationwide in the United States. The recall is due to a potential safety hazard where ceiling speakers may fall from their position and be pulled toward the MRI system by the magnetic field.

This recall affects all systems of this specific model. The source text does not specify a particular lot number or date range, indicating that the issue applies to the entire population of these units. No illnesses or injuries have been reported in the source text.

Consumers and healthcare facilities should contact Philips Medical Systems Nederlands for instructions on how to address this defect. The hazard involves the physical movement of components due to the magnetic field, posing a risk of injury from falling objects.

The recalled product

Product
Achieva 3.0T TX for PET, Model Number 781479. 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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