Recall Database
Philips North America Recalls
A hospital operating room with medical equipment (representative file photo). Specific recalled device: see recall details below. Photo: FDA / Public Domain.
- Recalls in database
- 19
- Agency
- FDA
- Years covered
- 2026
- Primary hazards
- Medical Device Defects (19)
Philips North America has 19 records, all FDA medical-device recalls, and all 19 classify as medical-device defects. Every notice was published in 2026, reflecting the current FDA ingestion window.
This is an FDA-only hub. Each row links to the FDA enforcement record with the recall classification and the firm's corrective action for a specific device.
How this hub is built. This page collects the 19 recall records tied to Philips North America in the current 411 Press recall dataset. Records are grouped by a normalized version of the recalling firm's name (normalizer version 2026-07-28.C3.2). Parent, subsidiary, and "doing business as" relationships are not merged unless the agency data states them, so a corporate family can appear under more than one name. Regulator for these records: FDA. They were published 2026. A recall count reflects how much recall activity fell inside the ingestion window — roughly February 2023 through May 2026, refreshed late May 2026 — not a ranking of relative safety. Larger manufacturers and higher-volume product lines file more notices. This is the current dataset, not an all-time total, and it grows as new notices are ingested. Every row links to the original agency notice.
2026 (19)
- Class II
Philips Upgrade to MR 7700 with MR Elastography (MRE).
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- Class II
Philips SmartPath to Ingenia Elition X with MR Elastography (MRE).
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- Class II
Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2.
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- Class II
Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- Class II
Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- Class II
Philips MR 7700 with MR Elastography (MRE).
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- Class II
Philips Ingenia Elition X with MR Elastography (MRE).
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- Class II
Philips Ingenia Elition S with MR Elastography (MRE).
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- Class II
Philips Ingenia Ambition X with MR Elastography (MRE).
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- Class II
Philips Ingenia Ambition S with MR Elastography (MRE).
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- Class II
Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF):
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- Class II
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF):
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- Class II
Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- Class II
Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF):
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- Class II
Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- Class II
Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- Class II
Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- Class II
Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- Class II
Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.