Philips Evolution Upgrade 1.5T MRI Stiffness Calculation Error
Philips North America is recalling Philips Evolution Upgrade 1.5T MRI systems with MR Elastography due to potential stiffness value errors that may result in incorrect voxel size settings 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 device. The hazard involves potential measurement errors in diagnostic imaging that could lead to misinterpretation of patient data, which constitutes a risk of harm to patients, though no actual illnesses or injuries are reported in the source text.
Plain-English summary
Philips North America is recalling the Philips Evolution Upgrade 1.5T with MR Elastography (MRE) medical imaging system. The recall affects 8 units distributed worldwide, including the United States and 37 other countries and territories.
The recalled devices may display stiffness value errors when specific image reconstruction parameters are used in combination with Resoundant's algorithm. This combination can cause the reconstruction voxel size settings in the default MRE scan protocol to display incorrectly as too small.
The affected models are REF 782116 (Serial Numbers 41527, 70949, 84741), REF 782148 (Serial Numbers 84560, 41277, 70769, 70983), and REF 782166 (Serial Number 70042). Healthcare facilities that operate these systems should contact Philips North America for corrective actions and guidance on affected imaging protocols.
The recalled product
- Product
- Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (REF): 782166.
- Manufacturer
- Philips North America
- Affected units
- 8
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 (10)
- 1. Model Number (REF): 782116. UDI: (01)00884838099722(21)41527
- (01)00884838099722(21)70949
- (01)00884838099722(21)84741. Serial Numbers: 41527
- 70949
- 84741. 2. Model Number (REF): 782148. UDI: (01)00884838108714(21)84560
- (01)00884838108714(21)41277
- (01)00884838108714(21)70769
- (01)00884838108714(21)70983. Serial Numbers: 84560
- 41277
- 70769
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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