FDA Device recall Z-2258-2026
Azurion system
- FDA Device
- Class II
- ongoing
- Published 2026-06-03
On 2026-06-03 the FDA classified a Class II recall of Azurion system by Philips Medical Systems Nederland B V, citing it was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2258-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-30 |
| Published | 2026-06-03 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | US |
Product
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12 (722227), Azurion 5 M20 (722228), Azurion 7 B12 (722067, 722225), Azurion 7 B20 (722068, 722226), Azurion 7 M12 (722078, 722223), Azurion 7 M20 (722079, 722224).
Reason
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.
Identifiers
| code_info | 1. Azurion 3 M12; Model: 722063; UDI: (01)00884838085275(21)122, (01)00884838085275(21)64, (01)00884838085275(21)56, (0…1. Azurion 3 M12; Model: 722063; UDI: (01)00884838085275(21)122, (01)00884838085275(21)64, (01)00884838085275(21)56, (01)00884838085275(21)131, (01)00884838085275(21)84, (01)00884838085275(21)132, (01)00884838085275(21)98, (01)00884838085275(21)108, (01)00884838085275(21)77, (01)00884838085275(21)82, (01)00884838085275(21)47, (01)00884838085275(21)80, (01)00884838085275(21)146, (01)00884838085275(21)102, (01)00884838085275(21)117, (01)00884838085275(21)2, (01)00884838085275(21)149, (01)00884838085275(21)99, (01)00884838085275(21)44, (01)00884838085275(21)3, (01)00884838085275(21)28, (01)00884838085275(21)144, (01)00884838085275(21)62, (01)00884838085275(21)119, (01)00884838085275(21)61, (01)00884838085275(21)22, (01)00884838085275(21)29, (01)00884838085275(21)40, (01)00884838085275(21)70, (01)00884838085275(21)30, (01)00884838085275(21)25, (01)00884838085275(21)19, (01)00884838085275(21)120, (01)00884838085275(21)121, (01)00884838085275(21)110, (01)00884838085275(21)16, (01)00884838085 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2258-2026%22
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