Medical device licence · 99999 · Class 3
AZURION
Yes: licensed in Canada
Licence status Issued (active); first licensed November 10, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99999
- Licence holder
- Philips Medical Systems Nederland B.V.Orange Village, OH, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- November 10, 2017
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AZURION 3 M12
- AZURION 3 M15
- AZURION 5 M12
- AZURION 5 M20
- AZURION 7 B12
- AZURION 7 B20
- AZURION 7 M12
- AZURION 7 M20
- AZURION UPGRADE TO R4
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “azurion”. A notice may cover another product or only some lots: read it to see what it covers.
- Azurion SystemsJuly 29, 2026 · Radiology · Performance · Type II
- Patient Tables of Philips Allura and Azurion systemsJuly 27, 2026 · Radiology · Performance · Type II
- Hard Disk Drives in Azurion and Allura SystemsMay 15, 2026 · Radiology · Performance · Type II
- Azurion SystemsMay 7, 2026 · Radiology · Performance · Type II
- Azurion and Allura Xper SystemsMay 6, 2026 · Radiology · Performance · Type II
- Allura Xper and Azurion SystemsMarch 17, 2026 · Radiology · Performance · Type II
- Azurion R2.1.10 and R2.2.10 systemsDecember 29, 2025 · Radiology · Performance · Type II
- Azurion R3.0 SystemsDecember 18, 2025 · Radiology · Performance · Type II
- Allura and Azurion SystemsAugust 15, 2025 · Radiology · Performance · Type II
- Azurion 7 M20June 19, 2025 · Radiology · Performance · Type II
- Azurion 7 SystemsJune 12, 2025 · Radiology · Performance · Type II
- Azurion and Allura SystemsJanuary 30, 2025 · Radiology · Performance · Type II
- Azurion and Allura SystemsDecember 30, 2024 · Radiology · Performance · Type II
- Philips Azurion, Allura Xper and Eleva SystemsSeptember 9, 2024 · Radiology · Performance · Type II
- Azurion 7 M20August 26, 2024 · Radiology · Performance · Type II
- Azurion 3 and 7August 14, 2024 · Radiology · Performance · Type II
- Philips Allura XPER, Allura Centron and Azurion SystemsJanuary 19, 2024 · Radiology · Performance · Type I
- Azurion 7 SystemJanuary 5, 2024 · Radiology · Performance · Type II
- Azurion 7 M20January 4, 2024 · Radiology · Performance · Type II
- Azurion 7 M20January 4, 2024 · Radiology · Performance · Type II
- Philips Allura and AzurionNovember 24, 2023 · Radiology · Performance · Type II
- Philips Multidiagnost Eleva, Allura Xper and Azurion systemsAugust 21, 2023 · Radiology · Performance · Type II
- Philips Allura Xper and Azurion 7 SystemsJuly 13, 2023 · Radiology · Performance · Type II
- Philips Azurion and Allura SystemsJune 22, 2023 · Radiology · Performance · Type II
- Philips Azurion SystemMarch 31, 2023 · Radiology · Performance · Type II
- ALLURA XPER and AZURION 7November 12, 2021 · Radiology · Software defect · Type II
- AZURION products (2021-09-27)October 15, 2021 · Medical devices · Medical devices · Type II
- AZURION 7 M20 (2020-04-09)May 1, 2020 · Medical devices · Medical devices · Type II
- AZURION 7 M20 (2020-04-03)May 1, 2020 · Medical devices · Medical devices · Type III
- Azurion 7 M20 (2020-03-03)April 15, 2020 · Medical devices · Medical devices · Type II
- AZURION 7 M20, B12 and B20 (2019-12-18)January 6, 2020 · Medical devices · Medical devices · Type II
- Azurion 7M12, M20, B12 & B20 (2019-11-04)November 15, 2019 · Medical devices · Medical devices · Type II
- Azurion 7 M12, M20 (2019-07-05)July 19, 2019 · Medical devices · Medical devices · Type II
- Azurion 7 M12, M20 (2019-07-05)July 19, 2019 · Medical devices · Medical devices · Type II
- Azurion 7 M12 and Azurion 7 M20 (2018-03-19)May 1, 2018 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.