The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0912-2019·Announced 2019-03-06

Philips Achieva 1.5T MRI System Recalled Due to Falling Speaker Hazard

Philips Medical Systems is recalling 11,226 Achieva 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 3/5 (High).

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 object in a medical environment) where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

Philips Medical Systems Nederlands is recalling 11,226 Achieva 1.5T Nuclear Magnetic Resonance Imaging Systems, Model Number 781343. The recall was initiated 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.

The affected systems were distributed nationwide in the United States. This recall applies to all systems of this model.

Healthcare facilities should contact Philips Medical Systems for instructions on how to address the potential hazard. The source text does not specify a deadline for action or report any injuries or illnesses associated with this defect.

The recalled product

Product
Achieva 1.5T, Model Number 781343. 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 →

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