Philips Ingenia 3.0T MRI System with Elastography Software Recall
Philips Ingenia 3.0T MRI systems with MR Elastography software may display incorrect stiffness values and voxel size settings when specific image reconstruction parameters are used, potentially 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: The source text presents no reports of patient harm, hospitalization, or clinical injury. The issue is a software parameter interaction that may cause measurement errors under specific conditions, making this a precautionary recall that aligns with FDA Class II classification criteria without evidence of actual adverse outcomes.
Plain-English summary
Philips North America is recalling the Philips Ingenia 3.0T with MR Elastography (MRE) across three model numbers (781342, 781377, and 782103). A total of 64 units have been distributed worldwide, including throughout the United States and to 46 additional countries.
The recall addresses a potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm. When these conditions occur, the reconstruction voxel size settings in the default MRE scan protocol may display as too small, which could impact the accuracy of elastography measurements.
Affected facilities should contact Philips North America for guidance on this issue. This is a Class II medical device recall as classified by the FDA.
The recalled product
- Product
- Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808
- Manufacturer
- Philips North America
- Affected units
- 64
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): 781342. UDI: (01)00884838055339(21)71693
- (01)00884838055339(21)71581
- (01)00884838055339(21)71582
- (01)00884838055339(21)71607
- (01)00884838055339(21)85216
- (01)00884838055339(21)71106
- (01)00884838055339(21)71477
- (01)00884838055339(21)71512
- (01)00884838055339(21)71966
- (01)00884838055339(21)71967
- (01)00884838055339(21)85147
- (01)00884838055339(21)85224
- (01)00884838055339(21)85318
- (01)00884838055339(21)71462
- (01)00884838055339(21)71619
- (01)00884838055339(21)85250
- (01)00884838055339(21)71002
- (01)00884838055339(21)71037
- (01)00884838055339(21)71269
- (01)00884838055339(21)71841
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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