Ingenia recallZ-1959-2026 · Philips North America · initiated Apr 14, 2026

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number

Z-1959-2026

Status

Open, Classified

Initiated by the company

Apr 14, 2026

Posted by the FDA

Apr 27, 2026

Recalling firm

Philips North America

Quantity

22 units

Product code

LNH

FDA submissions

K251808, K173079

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 description

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.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

• Ingenia Ingenia 3.0T CX

  Philips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging
  11 recalls59 reports
• Ingenia Ingenia 3.0T CX

  Philips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging
  7 recalls41 reports

Product lines

• IngeniaPhilips Medical Systems Nederland B.V. · 54 models · 479 reports · 138 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 98779).

• Z-1954-2026 · Open, Classified
  Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (REF): 782166.
• Z-1955-2026 · Open, Classified
  Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): 782162.
• Z-1956-2026 · Open, Classified
  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.…
• Z-1957-2026 · Open, Classified
  Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.
• Z-1958-2026 · Open, Classified
  Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K1730…
• Z-1960-2026 · Open, Classified
  Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139.
• Z-1961-2026 · Open, Classified
  Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 7…
• Z-1962-2026 · Open, Classified
  Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF): 782137.
• Z-1963-2026 · Open, Classified
  Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516…
• Z-1964-2026 · Open, Classified
  Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.
• Z-1965-2026 · Open, Classified
  Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112.
• Z-1966-2026 · Open, Classified
  Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.
• Z-1967-2026 · Open, Classified
  Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113.
• Z-1968-2026 · Open, Classified
  Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.
• Z-1969-2026 · Open, Classified
  Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.