Philips MRI Systems Recalled for Reversed Image Order in MobiView Software
Philips is recalling specific MRI systems with MobiView software due to a defect that reverses the order of fused multi-station scan images.
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 recall is classified as FDA Class II, and the defect involves a software error in image ordering without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Philips Medical Systems, Inc. is recalling 307 units of Ingenia, Intera, Achieva, and Achieve dStream MR systems. The affected units are running software versions R5.1.7 and R5.1.8 with the Mobi View software option. These diagnostic imaging systems were distributed nationwide in the United States and in numerous countries worldwide.
The recall is due to a software defect where the order of images is reversed when a fused series of a sagittal, coronal, or radial multi-station scan is generated in MobiView. This issue occurs specifically with software releases R5.1.7 and R5.1.8.
Healthcare facilities and users of these systems should contact Philips Medical Systems for further instructions on how to resolve the software issue.
The recalled product
- Product
- Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diagnostic imaging system.
- Manufacturer
- Philips Medical Systems, Inc.
- Hazard
- Affected units
- 307
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 (1)
- Software versions R5.1.7 and R5.1.8
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Philips Medical Systems, Inc.
See all →- ModeratePhilips Medical Systems Recalls Foot Switches for Bent Pedal Defect
FDA (Devices) · 2016-04-06
- ModeratePhilips MultiDiagnost Eleva Foot Switches Recalled for Bent Pedal Defect
FDA (Devices) · 2016-04-06
- SeverePhilips IntelliVue Information Center iX Software Recall for Alarm Failure
FDA (Devices) · 2015-12-16
- HighPhilips INTEGRIS Cardio System Ceiling Suspension Recall
FDA (Devices) · 2015-12-09
- SeverePhilips INTEGRIS Vascular System Recall for Ceiling Suspension Fall Risk
FDA (Devices) · 2015-12-09
Same hazard · software defect
See all →- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uMI 550 PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
Similar recalls
- ModeratePhilips MRI Systems Recalled for Incorrect Cross-Reference Lines in Spine Imaging
FDA (Devices) · 2015-10-28
- ModerateIngenia 1.5T MRI Systems Recalled for Alignment Errors
FDA (Devices) · 2025-05-28
- HighPhilips Ingenia Ambition X MRI Systems Alignment Error in MobiView
FDA (Devices) · 2025-05-28
- ModerateIngenia 3.0T MRI Systems Recalled for Image Alignment Errors
FDA (Devices) · 2025-05-28
- ModeratePhilips Intera 1.5T MRI Systems Recalled for Software Issue
FDA (Devices) · 2026-09-30
- ModeratePhilips Ingenia Elition X MRI System Alignment Error Recall
FDA (Devices) · 2025-05-28