Philips Healthcare Informatics, Inc.

Complete recall history across all FDA and CPSC categories — 4 total recalls

Philips Healthcare Informatics, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (4)

FDA medical device enforcement actions by Philips Healthcare Informatics, Inc.

Date Product Reason Class
Apr 19, 2019 IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be ... Images may potentially become corrupt while using the system. Class II
Jul 24, 2014 Philips IntelliSpace PACS 4.4 image management systems performs digital image... A problem was detected in the Philips IntelliSpace PAC 4.4 software where if... Class II
May 5, 2014 Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50... When using XIRIS Rio version (8.1.50.0) in conjuncture with iSite PACS a sync... Class II
Oct 14, 2013 Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a... Philips Healthcare became aware of a software problem with the IntelliSpace P... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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