The Recall Desk

Manufacturer

Philips North America

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

What the numbers show

Total
140
Critical
0
Severe
11
Most recent
2026-10-07

Of the 140 recalls from Philips North America we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 11 (8%) are Severe.

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.

26–50 of 140

  • 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-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-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-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-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-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-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-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
  • HighFDA (Devices)·Z-1212-2026·2026-02-04

    Ingenia Elition X systems recalled over elastography stiffness value errors

    Philips North America is recalling 31 units of the Ingenia Elition X MR system because exported MR Elastography stiffness maps may show stiffness value errors.

    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-1207-2026·2026-02-04

    Dual thread screw-in anchors recalled after reports of device failure

    Aju Pharm is recalling 400 units of the Genesis Dual Thread Screw-In Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.

    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-1213-2026·2026-02-04

    Hybrid suture anchors recalled after reports of breakage and pull out

    Aju Pharm is recalling 233 units of the Fixone Hybrid Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.

    Product
    MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1216-2026·2026-02-04

    SmartPath dStream upgrades recalled over elastography stiffness value errors

    Philips North America is recalling 3 units of the SmartPath to dStream for XR and 3.0T because exported MR Elastography stiffness maps may show stiffness value errors.

    Product
    SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1211-2026·2026-02-04

    Ingenia Elition S systems recalled over elastography stiffness value errors

    Philips North America is recalling 5 units of the Ingenia Elition S because exported MR Elastography stiffness maps may show stiffness value errors.

    Product
    Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1204-2026·2026-02-04

    Evolution Upgrade 1.5T systems recalled over elastography stiffness value errors

    Philips North America is recalling 3 units of the Evolution Upgrade 1.5T MR system because exported MR Elastography stiffness maps may show stiffness value errors.

    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-1209-2026·2026-02-04

    Ingenia Ambition S systems recalled over elastography stiffness value errors

    Philips North America is recalling 1 unit of the Ingenia Ambition S because exported MR Elastography stiffness maps may show stiffness value errors.

    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-1206-2026·2026-02-04

    Ingenia 1.5T systems recalled over elastography stiffness value errors

    Philips North America is recalling 10 units of the Ingenia 1.5T MR system because exported MR Elastography stiffness maps may show stiffness value errors.

    Product
    Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1208-2026·2026-02-04

    Ingenia 3.0T CX systems recalled over elastography stiffness value errors

    Philips North America is recalling 6 units of the Ingenia 3.0T CX MR system because exported MR Elastography stiffness maps may show stiffness value errors.

    Product
    Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1215-2026·2026-02-04

    SmartPath dStream 3.0T upgrades recalled over elastography stiffness errors

    Philips North America is recalling 1 unit of the SmartPath to dStream for 3.0T because exported MR Elastography stiffness maps may show stiffness value errors.

    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-1205-2026·2026-02-04

    Evolution Upgrade 3.0T systems recalled over elastography stiffness value errors

    Philips North America is recalling 1 unit of the Evolution Upgrade 3.0T MR system because exported MR Elastography stiffness maps may show stiffness value errors.

    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
  • HighFDA (Devices)·Z-1210-2026·2026-02-04

    Ingenia Ambition X systems recalled over elastography stiffness value errors

    Philips North America is recalling 21 units of the Ingenia Ambition X because exported MR Elastography stiffness maps may show stiffness value errors.

    Product
    Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1214-2026·2026-02-04

    MR 7700 upgrades recalled over elastography stiffness value errors

    Philips North America is recalling 6 units of the Upgrade to MR 7700 because exported MR Elastography stiffness maps may show stiffness value errors.

    Product
    Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1156-2026·2026-01-28

    Patient information centers recalled over a patch changing notification filters

    Philips North America is recalling 146 Patient Information Center iX units because a software patch modifies Mobile Event Notification filter settings without any indication to the user.

    Product
    Patient Information Center iX; Software Version Number: 4.5.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0597-2026·2025-12-17

    Fluoroscopy systems recalled after shipping without the source-to-skin distance spacer

    Philips is recalling 110 Azurion R3.0 systems shipped with a FlexArm stand but without the Source-to-Skin Distance spacer needed to meet the FDA minimum 38 cm requirement.

    Product
    Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0166-2026·2025-10-22

    Cardiac Workstation 7000 recalled after pinched power module wire caused short

    Philips is recalling 29 Cardiac Workstation 7000 units after environmental stress testing failed because a pinched power module wire inside the housing resulted in a short.

    Product
    Cardiac Workstation 7000; Model Number: 860441;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0165-2026·2025-10-22

    Cardiac workstations recalled after pinched power module wire caused short

    Philips is recalling 28 Cardiac Workstation 5000 units after environmental stress testing failed because a pinched power module wire inside the housing resulted in a short.

    Product
    Cardiac Workstation 5000; Model Number: 860439;
    Category
    Medical Device
    Distribution
    Distributed nationwide