Recall Register

Philips Healthcare: FDA recalls

FDA enforcement reports name Philips Healthcare as the recalling firm in 10 events. The events have 21 product records. The recalls started from 2014 to 2023. 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

10 events, newest first.

FDA enforcement events of Philips Healthcare
InitiatedProduct (first record)TypeClassRecordsStatus
2 Aug 2023Incisive CT, software version 5.0DeviceClass II1Ongoing
2 Feb 2022Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.xDeviceClass II1Terminated
24 Sep 2021Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)DeviceClass II1Ongoing
22 Sep 2021DigitalDiagnost C90DeviceClass II3Ongoing
26 May 2021Azurion systems with software release R2.0.xDeviceClass II1Completed
21 Dec 2018DigitalDiagnost C50, Stationary X-ray SystemDeviceClass II1Terminated
11 Jun 2018Allura Xper Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA,stent placing,atherectomies), pacemaker…DeviceClass II3Terminated
10 Nov 2015Philips Healthcare DigitalDiagnost stationary X-ray systemDeviceClass II2Terminated
6 Sep 2015Philips Healthcare Brilliance 64 Computed Tomography X-Ray SystemDeviceClass II7Terminated
13 Jan 2014InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908DeviceClass II1Terminated

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 Healthcare: events for each product type
TypeEvents
Device10
Philips Healthcare: events in each class
ClassEvents
Class II10
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
3

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 Healthcare, by the year that the recall started. The largest year is 2021, with 3 events.

Official channels

Cite this page

Recall Register. Philips Healthcare: FDA recalls. https://recallregister.com/firm/philips-healthcare/. 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, CA

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 Healthcare have?
Class II: 10 events. 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 Healthcare?
FDA event 93000, which the firm started on 2 Aug 2023. The first product in the record is: Incisive CT, software version 5.0
How many FDA recalls of Philips Healthcare have the status Ongoing?
3 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.