Philips Achieva 1.5T MRI Scanner Stiffness Calculation Error Recall
Philips is recalling Achieva 1.5T MRI systems with MR Elastography software due to potential stiffness value errors that may occur with specific image reconstruction parameters, causing incorrect voxel size display in the default scan protocol.
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: This is an FDA Class II recall of a medical imaging device with a risk of harm—inaccurate stiffness measurements could affect clinical diagnoses and patient care—but no reported illnesses, injuries, or patient harm are stated in the source text, placing it at the upper range of High severity per the rubric.
Plain-English summary
Philips North America is recalling the Achieva 1.5T with MR Elastography (MRE) due to a potential for stiffness value errors. The issue occurs when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, which can cause the reconstruction voxel size settings in the default MRE scan protocol to display incorrectly as too small.
Three units are affected worldwide, including systems distributed in the US and numerous other countries. The affected devices include Model Number (REF) 781196 with serial number 21957, and Model Number (REF) 781296 with serial numbers 32039 and 32095.
Affected facilities should contact Philips North America for further information about this device issue and any necessary remedial actions.
The recalled product
- Product
- Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.
- Manufacturer
- Philips North America
- Affected units
- 3
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 (2)
- (01)00884838004108(21)32095. Serial Numbers: 32039
- 32095.
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.
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