Recall Register

Philips North America: FDA recalls

FDA enforcement reports name Philips North America as the recalling firm in 30 events. The events have 128 product records. The recalls started from 2020 to 2026. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

30 events, newest first.

FDA enforcement events of Philips North America
InitiatedProduct (first record)TypeClassRecordsStatus
31 Jul 2026Philips Patient Information Center iX REF:866389DeviceClass II2Ongoing
14 Apr 2026Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.DeviceClass II19Ongoing
22 Dec 2025Patient Information Center iX; Software Version Number: 4.5.0DeviceClass II1Ongoing
3 Dec 2025Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.DeviceClass II13Ongoing
27 Oct 2025Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEMDeviceClass II1Ongoing
12 Sep 2025Cardiac Workstation 5000; Model Number: 860439;DeviceClass II2Ongoing
30 Jun 2025Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;DeviceClass II19Ongoing
29 May 2025Achieva XR Product Numbers: (1) 781153, (2) 781253;DeviceClass II9Ongoing
30 Aug 2024IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 (Model Number 866064), and MX550 (Model Number 866066)DeviceClass II1Ongoing
28 Feb 2024Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.XDeviceClass II2Ongoing
3 Jan 2024Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.DeviceClass II12Ongoing
29 Dec 2023Achieva 1.5T, Model No. 781178, 781196, 781296DeviceClass III6Ongoing
15 Dec 2023ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110DeviceClass II2Ongoing
15 Dec 2023BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791 453560279811 453560279801; 4x4 digit format 2170-3000A 2170-3001A 2170-3002A 2170-3003ADeviceClass I3Ongoing
7 Dec 2023Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871DeviceClass II1Ongoing
30 Nov 2023BrightView, Gamma Camera System, Product Code 882480.DeviceClass II3Ongoing
28 Nov 2023(1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model No. 866390 (3) PIC iX Hardware, Model No. 866424DeviceClass II2Ongoing
9 Oct 2023Spectral CT on Rails, Software Version 5.1.0, Model Number 728334DeviceClass II1Ongoing
9 Oct 2023Spectral CT on Rails, Software Version 5.1.0, Model Number 728334DeviceClass II1Ongoing
4 Oct 2023BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems.DeviceClass II6Ongoing
12 Jun 2023Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)DeviceClass II3Ongoing
12 Jun 2023Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)DeviceClass II3Ongoing
25 Apr 2023Incisive CT-Computed Tomography X-Ray System Model: 728143DeviceClass II4Ongoing
19 Apr 2023Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1DeviceClass II1Ongoing
20 Mar 2023Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814DeviceClass II2Ongoing
3 Mar 2023ProxiDiagnost N90 R.1.0DeviceClass II3Ongoing
18 Jan 2023IntelliVue G7m Anesthesia Gas Module, Product Number 866173DeviceClass II1Ongoing
6 Jan 2022Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), patient transportation systemDeviceClass II3Ongoing
15 Jul 2021(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)DeviceClass II1Ongoing
24 Dec 2020PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to V4.5.1.41989-Intended to produce cross-sectional images of the body Model Number: 728143DeviceClass II1Ongoing

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Philips North America: events for each product type
TypeEvents
Device30
Philips North America: events in each class
ClassEvents
Class II28
Class I1
Class III1
Share of the events of the firm in Class I
3%
Share of all events on the register in Class I
18%
Events with the status Ongoing
30

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Philips North America, by the year that the recall started. The largest year is 2023, with 16 events.

Official channels

Cite this page

Recall Register. Philips North America: FDA recalls. https://recallregister.com/firm/philips-north-america/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
MA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Philips North America have?
Class II: 28 events. Class I: 1 event. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Philips North America?
FDA event 99566, which the firm started on 31 Jul 2026. The first product in the record is: Philips Patient Information Center iX REF:866389
How many FDA recalls of Philips North America have the status Ongoing?
30 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.