Home/Recalls/FDA-Z-1959-2026

FDA DevicesClass II

Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

Name: Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.
Brand: Philips North America
SKU: FDA-Z-1959-2026
Availability: Discontinued
Rating: 1.0 (1 reviews)

Published: May 6, 2026Recall ID: Z-1959-2026Category: devicesCountry: US

Medical DeviceFDA Devices

Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

Recalling Firm: Philips North America

Reason for Recall / Hazard

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.

Product Description & Identification

Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

Affected Products

Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

Additional Source Details

Field	Value
City	Cambridge
State	MA
Event id	98779
Address 1	222 Jacobs St
Code info	1. Model Number (REF): 781271. UDI: (01)00884838068452(21)78017, (01)00884838068452(21)78013, (01)00884838068452(21)78014, (01)00884838068452(21)78034, (01)00884838068452(21)78058, (01)00884838068452(21)78073, (01)00884838068452(21)78075, (01)00884838068452(21)78092, (01)00884838068452(21)78112, (01)00884838068452(21)78123, (01)00884838068452(21)78201, (01)00884838068452(21)78202, (01)00884838068452(21)78215, (01)00884838068452(21)78217, (01)00884838068452(21)78239, (01)00884838068452(21)78247, (01)00884838068452(21)78260,(01)00884838068452(21)78286, (01)00884838068452(21)78287, (01)00884838068452(21)78026. Serial Numbers: 78017, 78013, 78014, 78034, 78058, 78073, 78075, 78092, 78112, 78123, 78201, 78202, 78215, 78217, 78239, 78247, 78260, 78286, 78287, 78026. 2. Model Number (REF): 782105. UDI: (01)00884838098312(21)78532, (01)00884838098312(21)78576. Serial Numbers: 78532, 78576.
Postal code	02141-2296
Report date	20260506
Product type	Devices
Product quantity	22 units
Reason for recall	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.
Voluntary mandated	Voluntary: Firm initiated
Recall initiation date	20260414
Initial firm notification	Letter
Center classification date	20260427

Overview

Recalling FirmPhilips North America
StatusOngoing
Risk LevelClass II
DistributionWorldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.

Recall Hazard Severity

High Alert (Class I)

Official Agency Alert

📢 Share Warning

Alert family and friends to keep them safe. Copy this quick alert message:

🚨 SAFETY ALERT: Philips North America - Philips Ingenia 3.0T CX with MR Elastography (MRE).     1. Model Number (REF): 781271.     2. Model Number (REF): 782105.       510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

Check if your household is affected:
https://therecallfile.com/recalls/philips-ingenia-3-0t-cx-with-mr-elastography-mre-1-model-number-ref-78/FDA-Z-1959-2026

WhatsApp Facebook

Join Alertlist

Get instant email updates whenever critical safety recalls like this are published.

Spread the WordPhilips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

Reason for Recall / Hazard

Product Description & Identification

Affected Products

Additional Source Details

Overview

📢 Share Warning

Join Alertlist

Install The Recall File App

Notification

Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

Reason for Recall / Hazard

Product Description & Identification

Affected Products

Additional Source Details

Overview

📢 Share Warning

Join Alertlist

Related Recalls

Field Safety Notices: 13 to 17 July 2026

Field Safety Notices: 13 to 17 July 2026

Field Safety Notices: 6 to 10 July 2026

Field Safety Notices: 6 to 10 July 2026

Key Sun Kids Cough Homeopathic Product Multipack Lozenges and Kids Cold Homeopathic Product Raspberry Lozenges

Key Sun Kids Cough Homeopathic Product Multipack Lozenges and Kids Cold Homeopathic Product Raspberry Lozenges

Install The Recall File App

Notification