Official recall record

Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (

US FDA — Medical Devices · 2026-04-14 · United StatesClass II

Issuing authority: US FDA — Medical Devices
Alert date: 2026-04-14
Country of alert: United States
Alert level: Class II
Alert type: recall
Barcode (EAN/GTIN): 00884838055339
Brand on record: Philips North America

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: US FDA — Medical Devices · United States · all filters

Same barcode in other registries

The same EAN appears in 4 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

2025-06-30 · US FDA — Medical Devices
Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;
2025-12-03 · US FDA — Medical Devices
Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.
2025-05-13 · US FDA — Medical Devices
Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;
2021-07-30 · US FDA — Medical Devices
Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can pro

Other recalls from this brand

2026-04-14 · US FDA — Medical Devices
Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF):
2026-04-14 · US FDA — Medical Devices
Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.
2026-04-14 · US FDA — Medical Devices
Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number

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