The Recall Desk
HighFDA (Devices)·Z-0870-2019·Announced 2019-03-06

Philips Prodiva CX MRI Systems Recalled for Ceiling Speaker Hazard

Philips is recalling Prodiva CX 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 objects due to magnetic field) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Philips Medical Systems Nederlands is recalling 11,226 Prodiva CX Nuclear Magnetic Resonance Imaging (MRI) systems, Model Number 781070. The recall covers all systems distributed nationwide in the United States.

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 hazard could result in injury to patients or staff if the speakers detach and strike individuals.

Healthcare facilities should contact Philips Medical Systems Nederlands for instructions on how to address this issue. Consumers and patients should not use the affected MRI systems until the issue is resolved.

The recalled product

Product
Prodiva CX, Model Number 781070. 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

See all →