Philips Ingenia 1.5T MRI System Stiffness Value Calculation Error Recall
Philips Ingenia 1.5T MRI systems with MR Elastography may display incorrect stiffness values and voxel size settings due to image reconstruction parameter combinations. The error affects 54 units distributed worldwide.
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: This is an FDA Class II recall involving a calculation/display error in a diagnostic imaging parameter. No reported illnesses, injuries, or hospitalizations are mentioned in the source text, and the hazard is a potential for inaccurate measurement rather than direct patient harm. This falls under minor functional/informational defects typical of Moderate severity.
Plain-English summary
Philips North America is recalling certain Philips Ingenia 1.5T magnetic resonance imaging (MRI) systems equipped with MR Elastography (MRE). The recalled devices include four model numbers (REF 781315, 781341, 781396, and 782115) across multiple 510(k) authorizations. A total of 54 units are affected.
The recall addresses a potential for stiffness value errors that can occur when specific ranges of image reconstruction parameters are used in combination with Resoundant's algorithm. When this combination occurs, the reconstruction voxel size settings in the default MRE scan protocol may display as too small, potentially leading to inaccurate tissue stiffness measurements during elastography imaging.
The affected devices have been distributed worldwide, including throughout the United States and to countries including Canada, Mexico, the United Kingdom, Germany, France, Italy, Spain, Australia, Japan, South Korea, and many others. Facilities using these systems should contact Philips North America for guidance on corrective action.
The recalled product
- Product
- Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808
- Manufacturer
- Philips North America
- Affected units
- 54
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 (20)
- 1. Model Number (REF): 781315. UDI: (01)00884838099715(21)61067
- (01)00884838099715(21)61058
- (01)00884838099715(21)61056. Serial Numbers: 61067 61058
- 61056. 2. Model Number (REF): 781341. UDI: (01)00884838055322(21)70229
- (01)00884838055322(21)84667
- (01)00884838055322(21)70311
- (01)00884838055322(21)70668
- (01)00884838055322(21)70845
- (01)00884838055322(21)70851
- (01)00884838055322(21)87151
- (01)00884838055322(21)87112
- (01)00884838055322(21)84322
- (01)00884838055322(21)84323
- (01)00884838055322(21)84228
- (01)00884838055322(21)84789
- (01)00884838055322(21)84261
- (01)00884838055322(21)84500
- (01)00884838055322(21)84556
- (01)00884838055322(21)87187
- (01)00884838055322(21)84840
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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