FDA Device recall Z-1155-2025

Azurion 5 M12

FDA Device
Class I
ongoing
Published 2025-02-26

On 2025-02-26 the FDA classified a Class I recall of Azurion 5 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-1155-2025
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 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).

Reason

Possibility of the patient falling from the table related to the mattress used on the patient table.

Identifiers

code_info	Catalog numbers: (1) 722227, (2) 722231(OUS ONLY); UDI-DI: (1) 00884838099227, (2) 00884838116740; Serial Numbers: (1)… Catalog numbers: (1) 722227, (2) 722231(OUS ONLY); UDI-DI: (1) 00884838099227, (2) 00884838116740; Serial Numbers: (1) 276, 238, 264, 63, 88, 135, 261, 19, 62, 83, 171, 191, 240, 133, 100, 93, 202, 115, 46, 134, 56, 53, 151, 99, 55, 54, 157, 158, 28, 241, 234, 164, 82, 299, 32, 12, 16, 272, 72, 64, 242, 176, 95, 2, 286, 75, 145, 71, 262, 143, 36, 120, 112, 5, 6, 7, 74, 188, 253, 280, 40, 87, 102, 146, 147, 77, 122, 141, 14, 15, 4, 163, 47, 48, 3, 1, 13, 123, 86, 269, 92, 173, 174, 121, 204, 258, 126, 245, 231, 81, 199, 166, 308, 105, 124, 49, 31, 26, 108, 247, 287, 170, 61, 292, 183, 168, 197, 195, 194, 149, 138, 140, 43, 273, 21, 17, 210, 22, 37, 221, 218, 219, 114, 101, 217, 220, 111, 294, 59, 85, 160, 67, 148, 96, 30, 20, 29, 263, 196, 137, 84, 236, 198, 118, 304, 23, 172, 230, 38, 159, 187, 125, 73, 60, 203, 211, 91, 52, 226, 216, 161, 128, 44, 206, 233, 103, 243, 260, 80, 281, 154, 252, 127, 205, 180, 106, 79, 98, 104, 293, 110, 113, 109, 177, 248, 227, 94, 259, 229, 301, 222, 162

code_info

Catalog numbers: (1) 722227, (2) 722231(OUS ONLY); UDI-DI: (1) 00884838099227, (2) 00884838116740; Serial Numbers: (1)…

Catalog numbers: (1) 722227, (2) 722231(OUS ONLY); UDI-DI: (1) 00884838099227, (2) 00884838116740; Serial Numbers: (1) 276, 238, 264, 63, 88, 135, 261, 19, 62, 83, 171, 191, 240, 133, 100, 93, 202, 115, 46, 134, 56, 53, 151, 99, 55, 54, 157, 158, 28, 241, 234, 164, 82, 299, 32, 12, 16, 272, 72, 64, 242, 176, 95, 2, 286, 75, 145, 71, 262, 143, 36, 120, 112, 5, 6, 7, 74, 188, 253, 280, 40, 87, 102, 146, 147, 77, 122, 141, 14, 15, 4, 163, 47, 48, 3, 1, 13, 123, 86, 269, 92, 173, 174, 121, 204, 258, 126, 245, 231, 81, 199, 166, 308, 105, 124, 49, 31, 26, 108, 247, 287, 170, 61, 292, 183, 168, 197, 195, 194, 149, 138, 140, 43, 273, 21, 17, 210, 22, 37, 221, 218, 219, 114, 101, 217, 220, 111, 294, 59, 85, 160, 67, 148, 96, 30, 20, 29, 263, 196, 137, 84, 236, 198, 118, 304, 23, 172, 230, 38, 159, 187, 125, 73, 60, 203, 211, 91, 52, 226, 216, 161, 128, 44, 206, 233, 103, 243, 260, 80, 281, 154, 252, 127, 205, 180, 106, 79, 98, 104, 293, 110, 113, 109, 177, 248, 227, 94, 259, 229, 301, 222, 162

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-1155-2025%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.