FDA Device recall Z-1157-2025

Azurion 7 B12

FDA Device
Class I
ongoing
Published 2025-02-26

On 2025-02-26 the FDA classified a Class I recall of Azurion 7 B12 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-1157-2025
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 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (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) 722067, (2) 722225, (3) 722235 (OUS ONLY); UDI-DI: (1) 00884838085350, (2) 00884838099265, (3) 008… Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY); UDI-DI: (1) 00884838085350, (2) 00884838099265, (3) 00884838116788; Serial Numbers: (1) 26, 150, 190, 278, 69, 141, 115, 221, 148, 46, 36, 42, 98, 123, 277, 92, 103, 192, 81, 57, 70, 225, 71, 131, 234, 109, 250, 114, 41, 214, 172, 173, 163, 104, 132, 147, 208, 244, 75, 133, 151, 188, 134, 22, 23, 268, 100, 101, 138, 54, 55, 276, 275, 105, 95, 32, 112, 97, 243, 224, 45, 108, 202, 113, 127, 76, 176, 165, 271, 272, 47, 256, 187, 154, 157, 265, 238, 207, 58, 169, 231, 226, 33, 159, 40, 120, 44, 121, 31, 28, 195, 196, 197, 179, 183, 185, 50, 78, 27, 85, 39, 91, 93, 94, 96, 239, 72, 119, 137, 189, 193, 117, 118, 89, 90, 167, 102, 84, 199, 73, 178, 129, 229, 252, 86, 79, 170, 227, 145, 63, 61, 49, 200, 21, 51, 194, 38, 186, 87, 56, 161, 110, 130, 80, 171, 245, 88, 175, 198, 139, 99, 37, 264, 266, 209, 255, 140, 59, 30, 206, 60, 156, 191, 142, 143, 144, 274, 52, 53, 107, 29, 232, 260, 64, 35, 203, 74, 48, 149, 251, 233, 222, 262,

code_info

Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY); UDI-DI: (1) 00884838085350, (2) 00884838099265, (3) 008…

Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY); UDI-DI: (1) 00884838085350, (2) 00884838099265, (3) 00884838116788; Serial Numbers: (1) 26, 150, 190, 278, 69, 141, 115, 221, 148, 46, 36, 42, 98, 123, 277, 92, 103, 192, 81, 57, 70, 225, 71, 131, 234, 109, 250, 114, 41, 214, 172, 173, 163, 104, 132, 147, 208, 244, 75, 133, 151, 188, 134, 22, 23, 268, 100, 101, 138, 54, 55, 276, 275, 105, 95, 32, 112, 97, 243, 224, 45, 108, 202, 113, 127, 76, 176, 165, 271, 272, 47, 256, 187, 154, 157, 265, 238, 207, 58, 169, 231, 226, 33, 159, 40, 120, 44, 121, 31, 28, 195, 196, 197, 179, 183, 185, 50, 78, 27, 85, 39, 91, 93, 94, 96, 239, 72, 119, 137, 189, 193, 117, 118, 89, 90, 167, 102, 84, 199, 73, 178, 129, 229, 252, 86, 79, 170, 227, 145, 63, 61, 49, 200, 21, 51, 194, 38, 186, 87, 56, 161, 110, 130, 80, 171, 245, 88, 175, 198, 139, 99, 37, 264, 266, 209, 255, 140, 59, 30, 206, 60, 156, 191, 142, 143, 144, 274, 52, 53, 107, 29, 232, 260, 64, 35, 203, 74, 48, 149, 251, 233, 222, 262,

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-1157-2025%22

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