Agency classClass IIOur severity:Severe FDA (Devices)·Z-0878-2019·Announced 2019-03-06

Philips MRI System Recall Due to Ceiling Speaker Magnetic Hazard

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

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a structural defect (ceiling speakers falling) in a high-risk medical device environment, which aligns with the rubric criterion for 'structural vehicle defect' or 'significant injury/property-damage reports' by analogy to physical hazards in critical infrastructure, warranting a Severe rating.

Plain-English summary

Philips Medical Systems Nederlands is recalling the Intera 1.5T Power/Pulsar Nuclear Magnetic Resonance Imaging System, Model Number 781105. The recall involves 11,226 units 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 MRI system by the magnetic field. This hazard could result in injury or property damage if the speakers detach and are attracted to the strong magnetic field of the scanner.

Healthcare facilities and users of these MRI systems should contact Philips Medical Systems Nederlands for instructions on how to address the issue. The source text does not specify a deadline or additional remediation steps beyond the potential hazard description.

The recalled product

Product: Intera 1.5T Power/Pulsar, Model Number 781105. Nuclear Magnetic Resonance Imaging System
Manufacturer: Philips Medical Systems Nederlands
Category: Medical Device — MRI System
Hazard: falling-object
magnetic-attraction
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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Same hazard · falling object