Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1952-2026·Announced 2026-05-06

Philips Achieva 1.5T MRI System MRE Protocol Parameter Error Recall

Philips Achieva 1.5T MRI systems with MR Elastography may display incorrect stiffness values and voxel size settings when certain image reconstruction parameters are used together, potentially affecting diagnostic accuracy.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recalls with no reported patient harm typically fall into the Moderate category. The source text describes a potential measurement error with no reported illnesses or injuries, making this a precautionary recall.

Plain-English summary

Philips North America has recalled one unit of the Philips Achieva 1.5T Initial system with MR Elastography (MRE), Model Number 781178, Serial Number 20088. The recall addresses a potential for stiffness value errors that can occur when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm. This combination leads to the reconstruction voxel size settings in the default MRE scan protocol displaying too small, which may result in inaccurate stiffness measurements.

The affected system has been distributed worldwide, including throughout the US and to 44 other countries listed by the FDA. Users of this specific equipment should contact Philips North America for guidance on firmware updates, protocol adjustments, or other corrective measures to ensure accurate MR Elastography measurements. FDA classified this recall as Class II.

The recalled product

Product: Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.
Manufacturer: Philips North America
Category: Medical Device — Diagnostic Imaging / MRI System
Hazard: measurement-error
image-reconstruction-parameter
Affected units: 1

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)

1. Model Number (REF): 781178. UDI: None. Serial Numbers: 20088.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 19 recalled by Philips North America 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 19 products in this recall →

Same manufacturer · Philips North America

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Same hazard · measurement error