Recall Register

PHILIPS MEDICAL SYSTEMS: FDA recalls

FDA enforcement reports name PHILIPS MEDICAL SYSTEMS as the recalling firm in 7 events. The events have 16 product records. The recalls started from 2016 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

7 events, newest first.

FDA enforcement events of PHILIPS MEDICAL SYSTEMS
InitiatedProduct (first record)TypeClassRecordsStatus
11 Jun 2026Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 UpgradesDeviceClass II3Ongoing
7 Mar 2026Philips Spectral CT on Rails. Model Number: 728334.DeviceClass II1Ongoing
25 Sep 2025Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X;DeviceClass II3Ongoing
13 Dec 2023Spectral CT on Rails: Software Version 5.1.0.X, model 728334.DeviceClass II2Ongoing
11 Feb 2022CombiDiagnost R90 1.0 (709030)DeviceClass II2Ongoing
24 Aug 2016Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.DeviceClass II4Terminated
8 Jan 2016DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621DeviceClass 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 MEDICAL SYSTEMS: events for each product type
TypeEvents
Device7
PHILIPS MEDICAL SYSTEMS: events in each class
ClassEvents
Class II7
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
5

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 MEDICAL SYSTEMS, by the year that the recall started. The largest year is 2016, with 2 events.

Official channels

Cite this page

Recall Register. PHILIPS MEDICAL SYSTEMS: FDA recalls. https://recallregister.com/firm/philips-medical-systems/. 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, OH

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 MEDICAL SYSTEMS have?
Class II: 7 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 MEDICAL SYSTEMS?
FDA event 99352, which the firm started on 11 Jun 2026. The first product in the record is: Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades
How many FDA recalls of PHILIPS MEDICAL SYSTEMS have the status Ongoing?
5 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.