MEDICAL DEVICE RECALLMODERATE

Philips Achieva 1.5T MRE

Philips recalls Achieva 1.5T MRE over stiffness value errors from incorrect voxel size settings.

What to do

If you use the Philips Achieva 1.5T with MR Elastography, contact Philips North America for instructions on updating the MRE scan protocol to correct the reconstruction voxel size settings. Do not use the default MRE protocol until the correction is applied.

Recalled

2026-04-14

Listed

2026-04-27

Updated

2026-09-08

Recall No.

Z-1951-2026

Agency

FDA

Firm

Philips North America

Recall ID

98779

Status

ONGOING

Why it was recalled

Philips is recalling the Achieva 1.5T with MR Elastography (MRE) because stiffness value errors can occur when specific image reconstruction parameters are used with Resoundant's algorithm, causing the reconstruction voxel size settings in the default MRE scan protocol to display too small. This could lead to inaccurate stiffness measurements, potentially affecting diagnosis.

Is mine affected?

This recall covers 19 products. Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Product	Recall #	UDI-DI
Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.	Z-1966-2026	00884838108684
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-1968-2026	00884838099746, 00884838108677, 00884838115743
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, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808	Z-1958-2026	00884838055339, 00884838055339, 00884838055339, 00884838055339, 00884838055339, 00884838055339, 00884838055339, 00884838055339, 00884838055339, 00884838055339, 00884838055339, 00884838055339, 00884838055339, 00884838055339, 00884838055339, 00884838055339, 00884838055339, 00884838055339, 00884838055339, 00884838055339
Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139.	Z-1960-2026	00884838090057, 00884838090057, 00884838098343, 00884838098343, 00884838098343, 00884838108639, 00884838108639
Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): 782162.	Z-1955-2026	00884838108660, 00884838108660, 00884838115736
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.	Z-1959-2026	00884838068452, 00884838068452, 00884838068452, 00884838068452, 00884838068452, 00884838068452, 00884838068452, 00884838068452, 00884838068452, 00884838068452, 00884838068452, 00884838068452, 00884838068452, 00884838068452, 00884838068452, 00884838068452, 00884838068452, 00884838068452, 00884838068452, 00884838068452
Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.	Z-1957-2026	00884838068445
Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.	Z-1951-2026	00884838004108, 00884838004108

Show all 19 products

Product	Recall #	UDI-DI
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, K223458, K230972, K232030, K251397, K251808	Z-1963-2026	00884838088115, 00884838088115, 00884838088115, 00884838088115, 00884838088115, 00884838088115, 00884838088115, 00884838088115, 00884838088115, 00884838088115, 00884838088115, 00884838088115, 00884838088115, 00884838088115, 00884838088115, 00884838088115, 00884838088115, 00884838088115, 00884838088115, 00884838088115
Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.	Z-1952-2026	–
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	Z-1956-2026	00884838099715, 00884838099715, 00884838099715, 00884838055322, 00884838055322, 00884838055322, 00884838055322, 00884838055322, 00884838055322, 00884838055322, 00884838055322, 00884838055322, 00884838055322, 00884838055322, 00884838055322, 00884838055322, 00884838055322, 00884838055322, 00884838055322, 00884838055322
Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.	Z-1964-2026	00884838104112, 00884838104112, 00884838104112, 00884838104112, 00884838104112, 00884838104112, 00884838104112, 00884838104112, 00884838104112, 00884838104112, 00884838104112, 00884838104112, 00884838104112, 00884838104112, 00884838112858, 00884838112858, 00884838112858, 00884838112858, 00884838112858, 00884838112858
Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.	Z-1953-2026	00884838004139
Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF): 782137.	Z-1962-2026	00884838088108, 00884838098329, 00884838098329, 00884838098329, 00884838108615, 00884838108615
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-1954-2026	00884838099722, 00884838099722, 00884838099722, 00884838108714, 00884838108714, 00884838108714, 00884838108714, 00884838115774
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): 782160.	Z-1961-2026	00884838090040, 00884838090040, 00884838090040, 00884838090040, 00884838090040, 00884838090040, 00884838090040, 00884838090040, 00884838090040, 00884838090040, 00884838090040, 00884838090040, 00884838090040, 00884838090040, 00884838090040, 00884838090040, 00884838090040, 00884838090040, 00884838090040, 00884838090040
Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112.	Z-1965-2026	00884838095076, 00884838095076, 00884838095076, 00884838098886, 00884838098886, 00884838098886
Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.	Z-1969-2026	00884838104402, 00884838104402, 00884838104402, 00884838104402, 00884838104402, 00884838104402, 00884838104402, 00884838104402, 00884838104402, 00884838104402, 00884838104402, 00884838104402, 00884838104402, 00884838104402, 00884838104402
Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113.	Z-1967-2026	00884838095083, 00884838095083, 00884838095083, 00884838095083, 00884838095083, 00884838095083, 00884838095083, 00884838095083, 00884838095083, 00884838095083, 00884838095083, 00884838098909, 00884838098909, 00884838098909

Where it was sold

Distributed nationwide.

Timeline

2026-04-14Firm initiated recall
2026-04-27Publicly announced
2026-04-28Listed on Recall Canary
2026-09-08Summary updated

Official source

View on U.S. Food and Drug Administration →

← Back to all recalls

Editorial summary by Recall Canary · summary updated 2026-09-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification