The Recall Desk
SevereFDA (Devices)·Z-0924-2019·Announced 2019-03-06

Philips MR-OR 1.5T MRI Systems Recalled for Falling Speaker Hazard

Philips is recalling 11,226 MR-OR 1.5T 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 recall involves a structural defect in a medical device where falling components could cause significant injury or property damage, meeting the criteria for a Severe rating.

Plain-English summary

Philips Medical Systems Nederlands is recalling 11,226 MR-OR 1.5T Nuclear Magnetic Resonance Imaging Systems, Model Number 781437. The recall covers systems 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 presents a risk of injury or property damage if the speakers detach.

Healthcare facilities and consumers with these specific MRI systems should contact Philips Medical Systems Nederlands for further instructions on how to address the issue. The recall is classified as Class II by the FDA.

The recalled product

Product
MR-OR 1.5T, Model Number 781437. 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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