Philips Ingenia Ambition S MRI Systems Recalled for Stiffness Value Errors
Philips is recalling certain Ingenia Ambition S MRI systems with MR Elastography software due to potential stiffness value errors that may occur when specific image reconstruction parameters are used in combination with Resoundant's algorithm.
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: FDA classified this as a Class II recall. The hazard involves potential measurement errors in a diagnostic imaging system that could lead to misdiagnosis or inappropriate clinical decisions, which constitutes a risk-of-harm scenario. No reported injuries or illnesses are stated in the source.
Plain-English summary
Philips North America is recalling certain Philips Ingenia Ambition S MRI systems equipped with MR Elastography (MRE) software. The recall affects 7 units of three specific model numbers (REF 781359, 782108, and 782139) distributed worldwide, including throughout the United States and to multiple countries.
The affected systems may display stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm. When this occurs, the reconstruction voxel size settings in the default MRE scan protocol may display incorrectly as too small. This could result in inaccurate elastography measurements and interpretation.
Healthcare facilities that have received any of the affected units should contact Philips North America for further guidance on remediation or replacement. The recall applies to systems with the specific serial numbers and UDI codes listed in the recall notice.
The recalled product
- Product
- Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139.
- Manufacturer
- Philips North America
- Affected units
- 7
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 (9)
- 1. Model Number (REF): 781359. UDI: (01)00884838090057(21)48218
- (01)00884838090057(21)48233. Serial Numbers: 48218
- 48233. 2. Model Number (REF): 782108. UDI: (01)00884838098343(21)48652
- (01)00884838098343(21)48551
- (01)00884838098343(21)48669. Serial Numbers: 48652
- 48551
- 48669. 3. Model Number (REF): 782139. UDI: (01)00884838108639(21)29076
- (01)00884838108639(21)29079. Serial Numbers: 29076
- 29079.
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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