FDA Device recall Z-1153-2025
Azurion 3 M12
- FDA Device
- Class I
- ongoing
- Published 2025-02-26
On 2025-02-26 the FDA classified a Class I recall of Azurion 3 M12 by Philips Medical Systems Nederland B V, citing possibility of the patient falling from the table related to the mattress used on the patient table.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1153-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-01-13 |
| Published | 2025-02-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | US |
Product
Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.
Reason
Possibility of the patient falling from the table related to the mattress used on the patient table.
Identifiers
| code_info | Catalog numbers: (1) 722063, (2) 722221; UDI-DI: (1) 00884838085275, (2) 00884838099203; Serial Numbers: (1) 96, 122, 1…Catalog numbers: (1) 722063, (2) 722221; UDI-DI: (1) 00884838085275, (2) 00884838099203; Serial Numbers: (1) 96, 122, 132, 131, 108, 84, 98, 56, 64, 101, 29, 139, 61, 75, 40, 77, 123, 154, 137, 150, 144, 135, 145, 127, 53, 121, 148, 55, 99, 143, 43, 25, 54, 151, 91, 85, 90, 86, 107, 89, 88, 44, 76, 47, 83, 93, 2, 130, 23, 73, 41, 97, 116, 117, 19, 50, 24, 149, 102, 38, 92, 72, 46, 27, 21, 78, 63, 119, 128, 28, 129, 22, 141, 69, 115, 100, 113, 106, 14, 16, 17, 70, 153, 18, 120, 105, 80, 146, 94, 104, 26, 51, 15, 59, 103, 81, 133, 48, 52, 79, 140, 3, 4, 110, 62, 30, 82, 71, 36, 37; (2) 108, 9, 54, 19, 153, 181, 6, 3, 7, 49, 115, 177, 85, 93, 171, 69, 182, 2, 60, 86, 122, 105, 44, 71, 159, 187, 8, 127, 59, 56, 126, 1, 52, 68, 145, 107, 128, 74, 97, 91, 132, 114, 130, 172, 35, 82, 134, 22, 162, 95, 67, 51, 66, 84, 61, 46, 102, 50, 53, 78, 79, 149, 99, 27, 157, 48, 32, 31, 158, 151, 141, 94, 146, 104, 119, 135, 124, 57, 161, 184, 25, 40, 77, 92, 131, 76, 163, 81, 73, 41, 29, 123, 75 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1153-2025%22
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