Manufacturer

Philips North America

126 recalls in our database name Philips North America as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 126

HighFDA (Devices)·Z-1951-2026·2026-05-06
Philips Achieva 1.5T MRI Scanner Stiffness Calculation Error Recall
Philips is recalling Achieva 1.5T MRI systems with MR Elastography software due to potential stiffness value errors that may occur with specific image reconstruction parameters, causing incorrect voxel size display in the default scan protocol.
Product
Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1960-2026·2026-05-06
Philips Ingenia Ambition S MRI Systems Recalled for Stiffness Value Errors
Philips is recalling certain Ingenia Ambition S MRI systems with MR Elastography software due to potential stiffness value errors that may occur when specific image reconstruction parameters are used in combination with Resoundant's algorithm.
Product
Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1954-2026·2026-05-06
Philips Evolution Upgrade 1.5T MRI Stiffness Calculation Error
Philips North America is recalling Philips Evolution Upgrade 1.5T MRI systems with MR Elastography due to potential stiffness value errors that may result in incorrect voxel size settings in the default scan protocol.
Product
Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (REF): 782166.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1961-2026·2026-05-06
Philips Ingenia Ambition X MRI Systems Stiffness Value Error Recall
Philips Ingenia Ambition X MRI systems with MR Elastography may produce incorrect stiffness values due to image reconstruction parameter errors, affecting diagnostic accuracy.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1957-2026·2026-05-06
Philips Ingenia 1.5T CX MRI Machine MRE Stiffness Measurement Error
Philips is recalling the Ingenia 1.5T CX MRI machine with MR Elastography because certain image reconstruction parameters may cause stiffness value measurement errors in the default scan protocol.
Product
Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1956-2026·2026-05-06
Philips Ingenia 1.5T MRI System Stiffness Value Calculation Error Recall
Philips Ingenia 1.5T MRI systems with MR Elastography may display incorrect stiffness values and voxel size settings due to image reconstruction parameter combinations. The error affects 54 units distributed worldwide.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1959-2026·2026-05-06
Philips Ingenia 3.0T CX MRI System MR Elastography Software Issue
Philips is recalling Ingenia 3.0T CX MRI systems with MR Elastography due to potential stiffness value errors caused by specific image reconstruction parameters and Resoundant algorithm settings, resulting in incorrect voxel size displays in the default MRE scan protocol.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1953-2026·2026-05-06
Philips Achieva 3.0T MR Elastography system stiffness value error recall
Philips is recalling the Achieva 3.0T with MR Elastography system due to potential stiffness value errors in image reconstruction when specific parameters are used, which may cause incorrect voxel size display in the default scan protocol.
Product
Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1955-2026·2026-05-06
Philips Evolution 3.0T MR Elastography upgrade stiffness calculation error
Philips Evolution upgrade 3.0T with MR Elastography systems may produce incorrect stiffness values when specific image reconstruction parameters are used, causing voxel size settings to display smaller than intended.
Product
Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): 782162.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1963-2026·2026-05-06
Philips Ingenia Elition X MRI Scanner Recall for Image Reconstruction Error
Philips is recalling Ingenia Elition X MRI scanners with MR Elastography due to potential errors in stiffness value measurements when specific image reconstruction parameters are used, which may cause incorrect voxel size display in the default scan protocol.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1968-2026·2026-05-06
Philips SmartPath to Ingenia Elition X MR Elastography Stiffness Value Errors
Philips is recalling three models of SmartPath to Ingenia Elition X with MR Elastography devices due to potential stiffness value errors when specific image reconstruction parameters are combined with Resoundant's algorithm.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1964-2026·2026-05-06
Philips MR 7700 MR Elastography device stiffness value error recall
Philips is recalling certain MR 7700 devices with MR Elastography due to potential stiffness value errors when specific image reconstruction parameters are used, which may cause voxel size settings to display incorrectly.
Product
Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1967-2026·2026-05-06
Philips SmartPath to dStream MR Elastography Software Parameter Error
Philips is recalling specific units of SmartPath to dStream for XR and 3.0T with MR Elastography due to potential stiffness value errors when certain image reconstruction parameters are used with Resoundant's algorithm, which may cause voxel size settings in the default MRE scan protocol to display incorrectly.
Product
Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1962-2026·2026-05-06
Philips Ingenia Elition S MRI stiffness value error correction
Philips Ingenia Elition S MRI systems with MR Elastography may display incorrect voxel size settings in the default scan protocol when certain image reconstruction parameters are used, potentially leading to stiffness value errors.
Product
Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF): 782137.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1952-2026·2026-05-06
Philips Achieva 1.5T MRI System MRE Protocol Parameter Error Recall
Philips Achieva 1.5T MRI systems with MR Elastography may display incorrect stiffness values and voxel size settings when certain image reconstruction parameters are used together, potentially affecting diagnostic accuracy.
Product
Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1966-2026·2026-05-06
Philips SmartPath dStream 3.0T MRI Scanner Software Parameter Error Recall
Philips is recalling one unit of the SmartPath to dStream 3.0T MRI scanner with MR Elastography due to potential stiffness value calculation errors when specific image reconstruction parameters are used.
Product
Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1958-2026·2026-05-06
Philips Ingenia 3.0T MRI System with Elastography Software Recall
Philips Ingenia 3.0T MRI systems with MR Elastography software may display incorrect stiffness values and voxel size settings when specific image reconstruction parameters are used, potentially affecting diagnostic accuracy.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1965-2026·2026-05-06
Philips SmartPath to dStream MR Elastography System Reconstruction Error
Philips is recalling certain SmartPath to dStream 1.5T MR Elastography systems due to potential stiffness value errors when specific image reconstruction parameters are used, which may cause incorrect voxel size settings in the default MRE scan protocol.
Product
Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1969-2026·2026-05-06
Philips MR 7700 MRE Upgrade MRI Equipment Stiffness Value Error Risk
Philips is recalling 15 units of its MR 7700 with MR Elastography upgrade due to potential stiffness value errors in MRI scans when specific image reconstruction parameters are used with the Resoundant algorithm.
Product
Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1215-2026·2026-02-04
Philips MRI systems may display incorrect elastography stiffness values
Philips SmartPath to dStream 3.0T MRI systems with software versions R11.1 and R12.1 may display inaccurate stiffness values when viewing MR Elastography maps in PACS viewers.
Product
SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1209-2026·2026-02-04
MR Imaging System May Display Incorrect Stiffness Values
Philips Ingenia Ambition S MR systems with software versions R11.1 or R12.1 may display incorrect tissue stiffness values when viewing MR Elastography data on PACS. Incorrect values could affect clinical interpretation.
Product
Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1204-2026·2026-02-04
Philips Evolution Upgrade 1.5T MR Systems May Display Inaccurate Elastography Values
Philips Evolution Upgrade 1.5T MR systems may display inaccurate stiffness values from MR Elastography scans when viewed in PACS, potentially affecting clinical interpretation.
Product
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1207-2026·2026-02-04
Ingenia 3.0T Magnetic Resonance Systems Stiffness Value Display Errors Recalled
Philips is recalling Ingenia 3.0T MR systems that may display incorrect stiffness values when viewing exported MR Elastography maps in PACS viewers, potentially affecting clinical diagnostic accuracy.
Product
Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1212-2026·2026-02-04
MRI stiffness measurement errors in Philips Ingenia Elition X systems
Philips is recalling Ingenia Elition X MRI systems due to potential errors in stiffness measurements displayed in elastography imaging. Affected users should verify measurement accuracy with clinical engineers.
Product
Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1205-2026·2026-02-04
MR System Software Issue Affects Stiffness Map Display Accuracy
Philips Evolution Upgrade 3.0T MR systems with software versions R11.1 and R12.1 may display inaccurate stiffness values in MR elastography images viewed in PACS, potentially affecting diagnostic accuracy.
Product
Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.
Category
Medical Device
Distribution
Distributed nationwide