Philips Healthcare Informatics, Inc.

FDA recalling firm · 4 enforcement events · 4 product records · 2013–2019 · CA

Philips Healthcare Informatics, Inc. has 4 FDA enforcement events on this register (4 product records) between 2013 and 2019: 4 device; the busiest year was 2014 with 2.

0% of its events are Class I; the most common class is Class II (4). 0 events are listed as ongoing; the recalling firm's address is in CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
19 Apr 2019	IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.	Device	Class II	1	Completed
24 Jul 2014	Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.	Device	Class II	1	Terminated
5 May 2014	Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system (RIS) is a computer system that assist radiology services in the storing, manipulating and retrieving of patient information. This included patient scheduling and tracking and workflow and reporting…	Device	Class II	1	Terminated
14 Oct 2013	Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare…	Device	Class II	1	Terminated

By type and class

Device4

Class II4

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Philips Healthcare Informatics, Inc. by year initiated.

Questions and answers

How many FDA recalls has Philips Healthcare Informatics, Inc. had?

4 enforcement events (4 product records) on this register, 2013–2019: 4 device.

Are any Philips Healthcare Informatics, Inc. recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Philips Healthcare Informatics, Inc. recalls?

4 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.