Atlas FDA

Azurion R2.0

FDA 510(k) clearance K181830 · decided 2018-08-02

Clearance details

K-number
K181830
Device name
Azurion R2.0
Applicant
Philips Medical Systems Nederland B.V.
Decision
Substantially Equivalent
Date received
2018-07-09
Decision date
2018-08-02
Days to decision
24 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 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 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
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 7 M20. Fluoroscopic X-Ray System. recall (Z-2134-2025)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2025-07-18
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
Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. recall (Z-1647-2023)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2024-09-30
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of th recall (Z-1145-2024)PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2024-02-16
Azurion recall (Z-2403-2023)Philips Medical Systems Nederland B.V.2023-09-07
Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used recall (Z-1809-2020)Philips North America, LLC2020-04-29
VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and recall (Z-1145-2020)Philips North America, LLC2020-02-10