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.
What this means for you
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
- Hazard
- measurement-error
- image-reconstruction-parameter
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.
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