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
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
Dec 15, 2025 Allura Xper FD10; Model Number: 722003; Philips has identified that in a limited number of impacted systems the drip ... Class II
Dec 15, 2025 Product Name: Allura Xper FD10C; Model number: 722001; Philips has identified that in a limited number of impacted systems the drip ... Class II
Dec 15, 2025 Allura Xper FD20; Model Number: 722028; Philips has identified that in a limited number of impacted systems the drip ... Class II
Dec 15, 2025 Allura Xper FD10/10; Model Number: 722027; Philips has identified that in a limited number of impacted systems the drip ... Class II
Dec 15, 2025 Allura Xper FD10F; Model Number: 722002; Philips has identified that in a limited number of impacted systems the drip ... Class II
Dec 12, 2025 Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes ... Six (6) identified software issues which may result in the following: system ... Class II
Dec 12, 2025 Philips Azurion system; Software Version Number: R3.1; Philips has identified two (2) software issues affecting device systems that ... Class II
Dec 8, 2025 Philips Azurion Systems R3.0. Includes the following label descriptions and c... Nine (9) identified software issues which may result in the following: loss o... Class II
Oct 2, 2025 Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Numb... The motorized longitudinal movement of the FlexArm stand may be inconsistent ... Class II
Sep 29, 2025 Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray... Over time some systems may experience loss of imaging functionality and/or po... Class II
Sep 3, 2025 Allura Xper FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005... Systems may not perform as intended due to the deterioration of certain inter... Class II
Sep 3, 2025 Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005... Systems may not perform as intended due to the deterioration of certain inter... Class II
Sep 3, 2025 Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated... Systems may not perform as intended due to the deterioration of certain inter... Class II
Sep 3, 2025 Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Ass... The BIOS battery may deplete faster than initially anticipated during the des... Class II
Sep 3, 2025 Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associ... The BIOS battery may deplete faster than initially anticipated during the des... Class II
Sep 3, 2025 Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Assoc... Systems may not perform as intended due to the deterioration of certain inter... Class II
Sep 3, 2025 Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035... The BIOS battery may deplete faster than initially anticipated during the des... Class II
Sep 3, 2025 Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K1... The BIOS battery may deplete faster than initially anticipated during the des... Class II
Sep 3, 2025 Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: ... The BIOS battery may deplete faster than initially anticipated during the des... Class II
Sep 3, 2025 Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers... Systems may not perform as intended due to the deterioration of certain inter... Class II
Sep 3, 2025 Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K1... The BIOS battery may deplete faster than initially anticipated during the des... Class II
Sep 3, 2025 Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated... The BIOS battery may deplete faster than initially anticipated during the des... Class II
Sep 3, 2025 Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; A... Systems may not perform as intended due to the deterioration of certain inter... Class II
Sep 3, 2025 Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K1306... The BIOS battery may deplete faster than initially anticipated during the des... Class II
Sep 3, 2025 Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; A... The BIOS battery may deplete faster than initially anticipated during the des... Class II
Sep 3, 2025 Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated... Systems may not perform as intended due to the deterioration of certain inter... Class II
Sep 3, 2025 Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K1306... The BIOS battery may deplete faster than initially anticipated during the des... Class II
Sep 3, 2025 Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K13084... Systems may not perform as intended due to the deterioration of certain inter... Class II
Sep 3, 2025 Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K1020... The BIOS battery may deplete faster than initially anticipated during the des... Class II
Sep 3, 2025 Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K1... The BIOS battery may deplete faster than initially anticipated during the des... Class II
Sep 3, 2025 Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K1... The BIOS battery may deplete faster than initially anticipated during the des... 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.

Explore More Recalls

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