Philips Medical Systems Nederland B.v.

Complete recall history across all FDA and CPSC categories — 162 total recalls

Philips Medical Systems Nederland B.v. 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 (162)

FDA medical device enforcement actions by Philips Medical Systems Nederland B.v.. Showing most recent 50.

Date Product Reason Class
Apr 30, 2026 Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722... It was identified that HDDs used in the PCs of Azurion and Allura systems may... Class II
Apr 30, 2026 Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (72206... It was identified that HDDs used in the PCs of Azurion and Allura systems may... Class II
Apr 28, 2026 Allura system; System Code Description (Model Numbers): Allura Xper FD10C (72... The deaeration hose in X-ray tube cooling units type CU3101, manufactured bet... Class II
Apr 28, 2026 Integris-Allura system; System Code Description (Model Numbers): Integris CV ... The deaeration hose in X-ray tube cooling units type CU3101, manufactured bet... Class II
Apr 28, 2026 Philips Azurion systems not configured with an optional auxiliary pan handle.... Potential safety issue with Philips Azurion systems, where longitudinal and t... Class II
Apr 28, 2026 Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (72206... The deaeration hose in X-ray tube cooling units type CU3101, manufactured bet... Class II
Mar 31, 2026 Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (72222... Potential for the bolts and plastic parts of the Cable Hose Carriers that hol... Class II
Mar 19, 2026 Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software me... Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) rati... Class II
Mar 5, 2026 Vue Motion V12. Product Number: 1017979. Potential that mis-ordered frames in Vue Motion during dynamic cine runs may ... Class II
Mar 3, 2026 ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026; Philips has identified instances where X-ray imaging may not be initiated or ... Class II
Mar 3, 2026 Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235; Philips has identified instances where X-ray imaging may not be initiated or ... Class II
Mar 3, 2026 Allura Xper FD10C; System Code: 722001; Philips has identified instances where X-ray imaging may not be initiated or ... Class II
Mar 3, 2026 Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS o... Philips has identified instances where X-ray imaging may not be initiated or ... Class II
Mar 3, 2026 ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028; Philips has identified instances where X-ray imaging may not be initiated or ... Class II
Mar 3, 2026 Allura Xper FD20/20; System Code: 722038; Philips has identified instances where X-ray imaging may not be initiated or ... Class II
Mar 3, 2026 Allura Xper FD20/15; System Code: 722058; Philips has identified instances where X-ray imaging may not be initiated or ... Class II
Mar 3, 2026 ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033; Philips has identified instances where X-ray imaging may not be initiated or ... Class II
Mar 3, 2026 ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027; Philips has identified instances where X-ray imaging may not be initiated or ... Class II
Mar 3, 2026 Allura Xper FD20/20 OR Table; System Code: 722039; Philips has identified instances where X-ray imaging may not be initiated or ... Class II
Mar 3, 2026 Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only); Philips has identified instances where X-ray imaging may not be initiated or ... Class II
Mar 3, 2026 Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233; Philips has identified instances where X-ray imaging may not be initiated or ... Class II
Mar 3, 2026 Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS O... Philips has identified instances where X-ray imaging may not be initiated or ... Class II
Mar 3, 2026 ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035; Philips has identified instances where X-ray imaging may not be initiated or ... Class II
Mar 3, 2026 Allura Xper FD20/10; System Code: 722029; Philips has identified instances where X-ray imaging may not be initiated or ... Class II
Mar 3, 2026 ALLURA Xper FD10F; System Code: 722002; Philips has identified instances where X-ray imaging may not be initiated or ... Class II
Mar 3, 2026 ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025; Philips has identified instances where X-ray imaging may not be initiated or ... Class II
Mar 3, 2026 Azurion 5 M12; System Code: (1)722227, (2)722231; Philips has identified instances where X-ray imaging may not be initiated or ... Class II
Mar 3, 2026 Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236; Philips has identified instances where X-ray imaging may not be initiated or ... Class II
Mar 3, 2026 Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229; Philips has identified instances where X-ray imaging may not be initiated or ... Class II
Mar 3, 2026 Allura Xper FD20/15 OR Table; System Code: 722059; Philips has identified instances where X-ray imaging may not be initiated or ... Class II
Mar 3, 2026 ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013; Philips has identified instances where X-ray imaging may not be initiated or ... Class II
Jan 26, 2026 Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only... Under certain conditions, the table may move unexpectedly when the Reset Geom... Class II
Jan 26, 2026 Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Softwa... Under certain conditions, the table may move unexpectedly when the Reset Geom... Class II
Jan 26, 2026 Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Sof... Under certain conditions, the table may move unexpectedly when the Reset Geom... Class II
Jan 26, 2026 Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)7... Under certain conditions, the table may move unexpectedly when the Reset Geom... Class II
Jan 26, 2026 Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version ... Under certain conditions, the table may move unexpectedly when the Reset Geom... Class II
Jan 26, 2026 Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Soft... Under certain conditions, the table may move unexpectedly when the Reset Geom... Class II
Jan 26, 2026 Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)7222... Under certain conditions, the table may move unexpectedly when the Reset Geom... Class II
Jan 26, 2026 Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Softwa... Under certain conditions, the table may move unexpectedly when the Reset Geom... Class II
Dec 15, 2025 Allura Xper FD20; Model Number: 722006; Philips has identified that in a limited number of impacted systems the drip ... Class II
Dec 15, 2025 Allura Xper FD10; Model Number: 722026; Philips has identified that in a limited number of impacted systems the drip ... Class II
Dec 15, 2025 Allura Xper FD20 Biplane; Model Number: 722013; Philips has identified that in a limited number of impacted systems the drip ... Class II
Dec 15, 2025 Allura Xper FD20 OR Table; Model Number: 722023; Philips has identified that in a limited number of impacted systems the drip ... Class II
Dec 15, 2025 Allura Xper FD20 Biplane; Model Number: 722008; Philips has identified that in a limited number of impacted systems the drip ... Class II
Dec 15, 2025 Allura Xper FD10; Model Number: 722010; Philips has identified that in a limited number of impacted systems the drip ... Class II
Dec 15, 2025 Allura Xper FD20/10; Model Number: 722029; Philips has identified that in a limited number of impacted systems the drip ... Class II
Dec 15, 2025 Allura Xper FD20; Model Number: 722012; Philips has identified that in a limited number of impacted systems the drip ... Class II
Dec 15, 2025 Allura Xper FD10/10; Model Number: 722005; Philips has identified that in a limited number of impacted systems the drip ... Class II
Dec 15, 2025 Allura Xper FD20/20; Model Number: 722038; Philips has identified that in a limited number of impacted systems the drip ... Class II
Dec 15, 2025 Allura Xper FD10/10; Model Number: 722011; Philips has identified that in a limited number of impacted systems the drip ... Class II

View all 162 device recalls →

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.

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