Z-1953-2026Class II

Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278

Name: Z-1953-2026 Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278
Creator: Philips North America
Published: 2026-04-14
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2026-04-14 / Open, Classified / root cause: software

FDA source

Philips North America began a recall of Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278 on 2026-04-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1953-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-14
Posted: 2026-04-27
Recalling firm: Philips North America LLC
Product: Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
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.
Root cause tag: software
FDA root cause: Under Investigation by 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.
Quantity in commerce: 1 unit
Distribution: 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.
Product codes and lots: 1. Model Number (REF): 781278. UDI: (01)00884838004139(21)38103. Serial Numbers: 38103.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1953-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1951-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-27
Z-1952-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-27
Z-1953-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-27
Z-1954-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-27
Z-1955-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-27
Z-1956-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-27
Z-1957-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-27
Z-1958-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-27
Z-1959-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-27
Z-1960-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-27
Z-1961-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-27
Z-1962-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-27
Z-1963-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-27
Z-1964-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-27
Z-1965-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-27
Z-1966-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-27
Z-1967-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-27
Z-1968-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-27
Z-1969-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-27

Product code LNH

K193215Class IIAchieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V. / cleared 2020-04-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)