Philips Medical Systems

Complete recall history across all FDA and CPSC categories — 12 total recalls

Philips Medical Systems 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 (12)

FDA medical device enforcement actions by Philips Medical Systems

Date Product Reason Class
Sep 25, 2025 Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Ve... Issue 1: The potential for unintentional continued gantry/couch movement when... Class II
Sep 25, 2025 Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.... Issue 1: The potential for unintentional continued gantry/couch movement when... Class II
Sep 25, 2025 Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Ver... Issue 1: The potential for unintentional continued gantry/couch movement when... Class II
Dec 13, 2023 Spectral CT on Rails: Software Version 5.1.0.X, model 728334. A software issue that can incorrectly label all captured images that may lead... Class II
Dec 13, 2023 Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 Chi... A software issue that can incorrectly label all captured images that may lead... Class II
Feb 11, 2022 CombiDiagnost R90 1.0 (709030) While performing a fluoroscopy examination, there is a potential that the Rad... Class II
Feb 11, 2022 CombiDiagnost R90 1.1 (709031) While performing a fluoroscopy examination, there is a potential that the Rad... Class II
Aug 24, 2016 Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography... The infant performance test did not meet the test specification for the Infan... Class II
Aug 24, 2016 Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X... The infant performance test did not meet the test specification for the Infan... Class II
Aug 24, 2016 Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray... The infant performance test did not meet the test specification for the Infan... Class II
Aug 24, 2016 Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray... The infant performance test did not meet the test specification for the Infan... Class II
Jan 8, 2016 DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radia... In DS/US proton planning, there is a correction factor used internally to the... 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.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

Explore More Recalls

Search recalls by category, state, reason, or firm across all our databases.