Atlas FDA

Azurion R2.1

FDA 510(k) clearance K200917 · decided 2020-05-01

Clearance details

K-number
K200917
Device name
Azurion R2.1
Applicant
Philips Medical Systems Nederland B.V.
Decision
Substantially Equivalent
Date received
2020-04-06
Decision date
2020-05-01
Days to decision
25 days
Clearance type
Special
Product code
OWB
Device class
2
Regulation number
892.1650
Medical specialty
Radiology
Advisory committee
Radiology
Location
Best Noord-Brabant, NL
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722 recall (Z-2931-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-08-10
Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, an recall (Z-2932-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-08-10
Philips Azurion under the following System Descriptions and corresponding model numbers: 1 recall (Z-2892-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-08-05
Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, recall (Z-2284-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-06-01
Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, recall (Z-2285-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-06-01
Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, recall (Z-2286-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-06-01
Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, recall (Z-2287-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-06-01
Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2. recall (Z-2288-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-06-01
Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0, R2.2. recall (Z-2289-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-06-01
Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, recall (Z-2290-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-06-01
Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, recall (Z-2291-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-06-01
Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the recall (Z-2225-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-05-21
Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), A recall (Z-2170-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-05-12
Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version N recall (Z-1344-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-02-11
Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only recall (Z-1345-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-02-11
Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Nu recall (Z-1346-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-02-11
Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Numb recall (Z-1347-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-02-11
Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Numb recall (Z-1348-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-02-11
Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); recall (Z-1349-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-02-11
Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All ve recall (Z-1350-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-02-11
Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Ve recall (Z-1351-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-02-11
Philips Azurion system; Software Version Number: R3.1; recall (Z-1113-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-01-16
Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding recall (Z-1079-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-01-14
Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following recall (Z-1091-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2026-01-14
Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSC recall (Z-0597-2026)Philips North America2025-12-09
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234; recall (Z-0719-2026)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-11-26
Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled recall (Z-2502-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-09-03
Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 7220 recall (Z-1969-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-06-12
Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221. recall (Z-1153-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-02-20
Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY). recall (Z-1154-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-02-20
Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY). recall (Z-1155-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-02-20
Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY). recall (Z-1156-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-02-20
Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY). recall (Z-1157-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-02-20
Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236. recall (Z-1158-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-02-20
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY). recall (Z-1159-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-02-20
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY); recall (Z-1160-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-02-20
Azurion 3 M12 System Code: (1) 722063 (2) 722221 recall (Z-1087-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-02-04
Azurion 3 M15 System Code: (1) 722064 (2) 722222 (3) 722280 recall (Z-1088-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-02-04
Azurion 5 M12 System Code: (1) 722227 (2) 722231 recall (Z-1089-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-02-04
Azurion 5 M20 System Code: (1) 722228 (2) 722232 (3) 722281 recall (Z-1090-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-02-04
Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235 recall (Z-1091-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-02-04
Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236 recall (Z-1092-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-02-04
Azurion 7 M12 System Code: (1) 722078 (2) 722223 (3) 722233 recall (Z-1093-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-02-04
Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 72 recall (Z-1094-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-02-04
Azurion IGTS Fixed Systems recall (Z-0229-2024)Philips North America2024-09-30
System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Az recall (Z-3165-2024)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2024-09-18
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluorosco recall (Z-2953-2024)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2024-09-04
Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1. recall (Z-2534-2024)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2024-08-08
Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, intervention recall (Z-1176-2024)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2024-02-22
Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventiona recall (Z-1177-2024)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2024-02-22