Philips Ingenia Elition S MRI stiffness value error correction
Philips Ingenia Elition S MRI systems with MR Elastography may display incorrect voxel size settings in the default scan protocol when certain image reconstruction parameters are used, potentially leading to stiffness value errors.
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: The source identifies this as an FDA Class II recall. No reported illnesses or injuries are stated. The hazard is a software or parameter-setting error affecting image reconstruction accuracy, not a structural or safety-critical hardware defect.
Plain-English summary
Philips North America is recalling the Philips Ingenia Elition S with MR Elastography (MRE) medical imaging systems 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, causing the reconstruction voxel size settings in the default MRE scan protocol to display incorrectly as too small.
The affected devices include three model numbers: REF 781357 (1 unit), REF 782106 (3 units), and REF 782137 (2 units). A total of 6 units have been distributed worldwide, including throughout the United States and to numerous countries.
Patients and healthcare providers should contact Philips North America regarding this issue for guidance on affected devices and potential remediation steps.
The recalled product
- Product
- Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF): 782137.
- Manufacturer
- Philips North America
- Affected units
- 6
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 (6)
- (01)00884838098329(21)46292
- (01)00884838098329(21)46317. Serial Numbers: 46243
- 46292
- 46317. 3. Model Number (REF): 782137. UDI: (01)00884838108615(21)64034
- (01)00884838108615(21)64045. Serial Numbers: 64034
- 64045.
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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