Philips Ingenia Ambition X MRI Systems Stiffness Value Error Recall
Philips Ingenia Ambition X MRI systems with MR Elastography may produce incorrect stiffness values due to image reconstruction parameter errors, affecting diagnostic accuracy.
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 potential for diagnostic measurement error in an imaging device. No reported injuries or illnesses are stated in the source, and the hazard is a parameter-configuration issue that may affect measurement accuracy rather than pose direct physical harm.
Plain-English summary
Philips North America is recalling Philips Ingenia Ambition X MRI systems equipped with MR Elastography (MRE) functionality. The recall affects 86 units distributed worldwide, including across the United States and numerous international markets.
The issue involves potential stiffness value errors that can occur when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm. When this combination occurs, the reconstruction voxel size settings in the default MRE scan protocol may display settings that are too small, which could lead to incorrect stiffness value calculations and impact diagnostic accuracy.
Affected devices include four model numbers: REF 781356, REF 782109, REF 782138, and REF 782160. Customers who operate these systems should contact Philips North America for guidance on addressing this issue and verifying whether their specific device and settings may be affected.
The recalled product
- Product
- Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160.
- Manufacturer
- Philips North America
- Affected units
- 86
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): 781356. UDI: (01)00884838090040(21)47056
- (01)00884838090040(21)47272
- (01)00884838090040(21)47189
- (01)00884838090040(21)47310
- (01)00884838090040(21)47006
- (01)00884838090040(21)47029
- (01)00884838090040(21)47044
- (01)00884838090040(21)47068
- (01)00884838090040(21)47196
- (01)00884838090040(21)47206
- (01)00884838090040(21)47208
- (01)00884838090040(21)47237
- (01)00884838090040(21)47260
- (01)00884838090040(21)47289
- (01)00884838090040(21)47291
- (01)00884838090040(21)47294
- (01)00884838090040(21)47303
- (01)00884838090040(21)47305
- (01)00884838090040(21)47322
- (01)00884838090040(21)47325
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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