FDA recall record · openFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
197 FDA recalls on record (2023–2026) — 197 device. 197 still ongoing.
20
Class I (most serious)
177
Class II
0
Class III
197
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wir 22
Possibility of the patient falling from the table related to the mattress used on the patient table. 20
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura 19
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not insta 16
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, th 15
Recalls
Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013. Class I 2025-01-13 Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY). Class I 2025-01-13 Allura CV20; Catalog numbers: 722031 Class I 2025-01-13 Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY); Class I 2025-01-13 Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221. Class I 2025-01-13 Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028. Class I 2025-01-13 Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025. Class I 2025-01-13 Allura Xper FD20/15; Catalog numbers: 722058 Class I 2025-01-13 Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY). Class I 2025-01-13 Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035. Class I 2025-01-13 Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236. Class I 2025-01-13 Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY). Class I 2025-01-13 Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY). Class I 2025-01-13 Allura Xper FD20/10; Catalog numbers: 722029 Class I 2025-01-13 Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026, Class I 2025-01-13 Allura Xper FD10C; Catalog number: 722001 Class I 2025-01-13 Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY). Class I 2025-01-13 Allura Xper FD20/20; Catalog numbers: 722038 Class I 2025-01-13 Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY). Class I 2025-01-13 Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027. Class I 2025-01-13 ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013; Class II 2026-03-03 Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 ( Class II 2026-04-28 Allura Xper FD20/15 OR Table; System Code: 722059; Class II 2026-03-03 Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229; Class II 2026-03-03 Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2. Class II 2026-01-26 Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236; Class II 2026-03-03 Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - Al Class II 2026-01-26 Azurion 5 M12; System Code: (1)722227, (2)722231; Class II 2026-03-03 Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R Class II 2026-01-26 ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025; Class II 2026-03-03 Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended Class II 2026-03-19 ALLURA Xper FD10F; System Code: 722002; Class II 2026-03-03 Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X Class II 2026-01-26 Allura Xper FD20/10; System Code: 722029; Class II 2026-03-03 Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number - Class II 2026-01-26 ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035; Class II 2026-03-03 Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions an Class II 2026-04-28 Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only); Class II 2026-03-03 Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233; Class II 2026-03-03 Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Class II 2026-03-31 Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, Class II 2026-01-26 Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Class II 2026-04-30 Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only); Class II 2026-03-03 Allura Xper FD20/20 OR Table; System Code: 722039; Class II 2026-03-03 Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2. Class II 2026-01-26 Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR T Class II 2026-04-30 ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027; Class II 2026-03-03 Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), Integ Class II 2026-04-28 Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions: Class II 2026-01-26 ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033; Class II 2026-03-03 Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura X Class II 2026-04-28 Allura Xper FD20/15; System Code: 722058; Class II 2026-03-03 Allura Xper FD20/20; System Code: 722038; Class II 2026-03-03 ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028; Class II 2026-03-03 Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only); Class II 2026-03-03 Vue Motion V12. Product Number: 1017979. Class II 2026-03-05 Allura Xper FD10C; System Code: 722001; Class II 2026-03-03 Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235; Class II 2026-03-03 ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026; Class II 2026-03-03 Intera 1.5T Master/Nova, Model Number: 781106; Class II 2025-03-24 IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089. Class II 2025-04-07 Azurion 3 M12 System Code: (1) 722063 (2) 722221 Class II 2025-01-13 Philips Azurion system; Software Version Number: R3.1; Class II 2025-12-12 SmartPath to dStream for 3.0T, Model Number: 782145; Class II 2025-03-24 Allura Xper FD10F; Model Number: 722002; Class II 2025-12-15 Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K13 Class II 2025-09-03 Intera 1.5T Explorer/Nova Dual, Model Number: 781108; Class II 2025-03-24 Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K1615 Class II 2025-09-03 Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K1306 Class II 2025-09-03 Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K1419 Class II 2025-09-03 Allura Xper FD10/10; Model Number: 722027; Class II 2025-12-15 Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K1 Class II 2025-09-03 IntelliSpace Cardiovascular, Software 8.0.0.4. Class II 2025-08-08 Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K1 Class II 2025-09-03 Allura Xper FD20; Model Number: 722028; Class II 2025-12-15 Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, Class II 2025-09-03 Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system Class II 2025-09-29 Product Name: Allura Xper FD10C; Model number: 722001; Class II 2025-12-15 SmartPath to dStream for 1.5T, Model Number: 782146; Class II 2025-03-24 Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. M Class II 2025-12-08 Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334; Class II 2025-02-28 Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, Class II 2025-09-03 Allura Xper FD10; Model Number: 722003; Class II 2025-12-15 Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, Class II 2025-09-03 Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K16 Class II 2025-09-03 Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162 Class II 2025-09-03 Intera 1.0T Omni/Stellar, Model Number: 781102; Class II 2025-03-24 Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K16 Class II 2025-09-03 Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235 Class II 2025-01-13 Allura CV20 System Code: 722031 Class II 2025-01-13 Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, Class II 2025-09-03 Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236 Class II 2025-01-13 Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K13084 Class II 2025-09-03 Enterprise 1.5T, Model Number: 781145; Class II 2025-03-24 AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028 Class II 2025-01-13 Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K16 Class II 2025-09-03 Allura Xper FD10/10; Model Number: 722011; Class II 2025-12-15 Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, Class II 2025-09-03 Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K13329 Class II 2025-09-03 AlluraXperFD20/10 System Code: (1) 722029 Class II 2025-01-13 Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, Class II 2025-09-03 Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K1419 Class II 2025-09-03 AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013 Class II 2025-01-13 Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979 Class II 2025-09-03 Allura Xper FD20/20; Model Number: 722038; Class II 2025-12-15 Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, Class II 2025-09-03 Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K1 Class II 2025-09-03 Allura Xper FD10/10; Model Number: 722005; Class II 2025-12-15 Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K13 Class II 2025-09-03 Intera 1.5T Omni/Stellar, Model Number: 781104; Class II 2025-03-24 Intera 0.5T Standard, Model Number: 781101; Class II 2025-03-24 Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223 Class II 2025-01-13 Allura Xper FD20; Model Number: 722012; Class II 2025-12-15 Azurion 7 M20. Fluoroscopic X-Ray System. Class II 2025-06-04 Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K1 Class II 2025-09-03 AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035 Class II 2025-01-13 AlluraXperFD20/15 System Code: (1) 722058 Class II 2025-01-13 Intera 3.0T Quasar Dual, Model Number: 781150; Class II 2025-03-24 Intera 1.5T Power/Pulsar, Model Number: 781105; Class II 2025-03-24 Allura Xper FD20/10; Model Number: 722029; Class II 2025-12-15 Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresp Class II 2025-08-01 Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper Class II 2025-06-30 Azurion 5 M12 System Code: (1) 722227 (2) 722231 Class II 2025-01-13 AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027 Class II 2025-01-13 Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corres Class II 2025-12-12 Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corre Class II 2025-08-01 Intera 1.5T R11, Model Number: 781170; Class II 2025-03-24 Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026 Class II 2025-01-13 Azurion 5 M20 System Code: (1) 722228 (2) 722232 (3) 722281 Class II 2025-01-13 Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, Class II 2025-09-03 Allura Xper FD10; Model Number: 722010; Class II 2025-12-15 Allura Xper FD20/20 System Code: (1) 722038 Class II 2025-01-13 Azurion 7 M12 System Code: (1) 722078 (2) 722223 (3) 722233 Class II 2025-01-13 Intera 1.5T, Model Numbers: 781195 and 781295; Class II 2025-03-24 Intera 1.0T Power/Pulsar, Model Number: 781103; Class II 2025-03-24 Allura Xper FD20 Biplane; Model Number: 722008; Class II 2025-12-15 Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, ( Class II 2025-05-28 Intera CV, Model Number: 781107; Class II 2025-03-24 Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, Class II 2025-09-03 Azurion 3 M15 System Code: (1) 722064 (2) 722222 (3) 722280 Class II 2025-01-13 Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K1615 Class II 2025-09-03 Allura Xper FD20 OR Table; Model Number: 722023; Class II 2025-12-15 Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234; Class II 2025-10-02 Allura Xper FD20 Biplane; Model Number: 722013; Class II 2025-12-15 AlluraXper FD20 Biplane OR Table System Code: (1) 722020 (2) 722025 Class II 2025-01-13 Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model Class II 2025-08-01 Allura Xper FD10C System Code: (1) 722001 Class II 2025-01-13 Allura Xper FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K1615 Class II 2025-09-03 Allura Xper FD10; Model Number: 722026; Class II 2025-12-15 Allura Xper FD20; Model Number: 722006; Class II 2025-12-15 Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Class II 2024-11-11 Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100. Class II 2024-05-16 Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013, Software Version Number 8.1 Class II 2024-05-16 Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for I Class II 2024-07-15 Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected Class II 2024-01-02 Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected Class II 2024-01-02 System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7 M Class II 2024-08-22 Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surg Class II 2024-02-06 Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of Class II 2024-05-02 Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722 Class II 2024-08-08 Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected Class II 2024-01-02 Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive sur Class II 2024-02-06 Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Number Class II 2024-08-06 Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected Class II 2024-01-02 System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allur Class II 2024-08-22 System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 722039 Allura Xper FD20/20 OR Table 722038 A Class II 2024-08-22 System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost Eleva with Flat Detector 708036 MultiDia Class II 2024-08-22 Philips Zenition 50, Model Number: 718096 Class II 2024-10-07 Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100. Class II 2024-05-16 Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surg Class II 2024-02-06 Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used Class II 2024-01-02 Philips Zenition 70, Model Number: 718133 Class II 2024-10-07 Philips IntelliSpace Cardiovascular software, Model 830089. Class II 2024-04-04 Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) A Class II 2023-03-21 Azurion 7 M20. X-ray Image guided Therapy System. Class II 2023-06-12 Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 wit Class II 2023-12-07 Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12 -7 Class II 2023-12-12 Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with Class II 2023-12-07 Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as w Class II 2023-07-20 SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6 Class II 2023-02-20 Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems Class II 2023-08-15 Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12) Class II 2023-12-08 Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 Class II 2023-12-07 Allura Xper series Class II 2023-07-19 Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 wit Class II 2023-12-07 Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Ro Class II 2023-12-07 Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 wit Class II 2023-12-07 Azurion Class II 2023-07-19 Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems Class II 2023-06-30 Allura Xper FD10 and FD20. X-ray Imaging System. Class II 2023-06-12 Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 Class II 2023-12-07 2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1 Class II 2023-02-20 MultiDiagnost-Eleva Class II 2023-07-19 Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion Class II 2023-11-03 Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura Xper FD10C 722003 Allura Xper FD10 722006 Class II 2023-11-03 Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12) Class II 2023-12-08 Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Ro Class II 2023-12-07
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.