Ingenia Ambition S MRI devices recalled for alignment errors
Philips is recalling certain Ingenia Ambition S MRI devices due to potential alignment errors in the cross reference line functionality when reviewing images with the MobiView application.
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 of a medical device with no reported illnesses or injuries. The hazard is a software functionality error that could affect image interpretation but no adverse health consequences have been documented.
Plain-English summary
Philips North America LLC is recalling certain Ingenia Ambition S magnetic resonance imaging (MRI) devices due to a potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
The affected devices are Model Numbers 781359, 782108, and 782139. A total of 152 units have been distributed worldwide, including 25 units in the United States and 127 units outside the U.S. across multiple countries.
Misalignment of the cross reference line could impact the accuracy of image review. Affected users should contact Philips for further information regarding this issue and any necessary corrective actions.
The recalled product
- Product
- Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;
- Manufacturer
- Philips North America Llc
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)
- Model Numbers: (1) 781359
- (2) 782108
- (3) 782139
- UDI-DI: (1) 00884838090057
- (2) 00884838009813
- (3) 00884838098299
- Serial Numbers: (1) 48001
- 48005
- 48009
- 48011
- 48014
- 48016
- 48023
- 48033
- 48034
- 48043
- 48045
- 48047
- 48122
- 48154
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 recalled by Philips North America Llc 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.
See all 18 products in this recall →Related recalls
Same manufacturer · Philips North America Llc
See all →- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- ModeratePhilips Achieva 1.5T MRI Systems Recalled for Software Memory Issue
FDA (Devices) · 2026-09-30
- ModeratePhilips MR 7700 MRI Systems Recalled for Software Issue
FDA (Devices) · 2026-09-30
- ModeratePhilips Ingenia MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
- ModeratePhilips MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
Same hazard · alignment error
See all →- HighPhilips Ingenia Ambition X MRI Systems Alignment Error in MobiView
FDA (Devices) · 2025-05-28
- HighSmartPath to dStream 3.0T Medical Device Recall for Software Error
FDA (Devices) · 2025-05-28
- ModerateEvolution Upgrade 1.5T imaging system alignment error recall
FDA (Devices) · 2025-05-28
- ModeratePhilips Upgrade to MR 7700 Medical Device Alignment Error Recall
FDA (Devices) · 2025-05-28
- ModerateIngenia 3.0T MRI Systems Recalled for Image Alignment Errors
FDA (Devices) · 2025-05-28
Similar recalls
- ModeratePhilips Ingenia Ambition MRI Software Recall for Memory Limit Issue
FDA (Devices) · 2026-09-30
- HighPhilips Ingenia Ambition S MRI Patient Support Floor Plate May Be Incorrectly Installed
FDA (Devices) · 2024-04-24
- HighIngenia Ambition S systems recalled over elastography stiffness value errors
FDA (Devices) · 2026-02-04
- HighPhilips Ingenia Ambition S MRI Systems Recalled for Stiffness Value Errors
FDA (Devices) · 2026-05-06
- HighPhilips Ingenia Ambition S MRI systems recalled for potential fire hazard
FDA (Devices) · 2024-05-29
- ModeratePhilips Ingenia Ambition MRI Systems Recalled for Incorrect DTI Data Exports
FDA (Devices) · 2026-10-07