FDA Device recall Z-1344-2026
Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229
- FDA Device
- Class II
- ongoing
- Published 2026-02-18
On 2026-02-18 the FDA classified a Class II recall of Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229 by Philips Medical Systems Nederland B V, citing under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1344-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-01-26 |
| Published | 2026-02-18 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | US |
Product
Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X
Reason
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Identifiers
| code_info | System Model Numbers: (1) 722063, (2) 722221, (3) 722229; UDI-DIs: (1) 884838085275, (2) 884838099203, (3) 884838116726; Serial Numbers: All; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Other recalls by Philips Medical Systems Nederland B V
- Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058
FDA Device · Class II · 2026-08-19 · Philips Medical Systems Nederland B V - Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and…
FDA Device · Class II · 2026-08-19 · Philips Medical Systems Nederland B V - Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 72222…
FDA Device · Class II · 2026-08-19 · Philips Medical Systems Nederland B V - Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10
FDA Device · Class II · 2026-08-12 · Philips Medical Systems Nederland B V - Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12
FDA Device · Class II · 2026-08-12 · Philips Medical Systems Nederland B V
All Philips Medical Systems Nederland B V recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1344-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.