Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808
FDA Recall Z-1956-2026 · Posted 2026-04-27
Recalling FirmPhilips North America
Recall StatusOpen, Classified
Product CodeLNH
Date Initiated2026-04-14
Product Quantity54 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.
Firm Action
Philips Medical notified consignees on about 04/14/2026 via letter. Consignees were made aware of the issue, affected units, and instructed to continue to use MDE as per established guidelines, manually update the scan protocol settings according to the directions provided to prevent the issue from occurring, and continue using the systems in accordance with their intended use.
Consignees were also instructed to circulate the notice to all users for awareness, retain the Urgent Medical Device letter with affected systems until the software upgrade is installed and complete and return the provided response form.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide - 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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K213583Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V. · 2022-05-16K193215Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V. · 2020-04-10K183063Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V. · 2019-02-14K173079Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4Philips Medical Systems Nederland B.V. · 2018-04-04K163116Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3Philips Medical Systems Nederland B.V. · 2017-01-06
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.