FDA Device recall Z-1159-2025

Azurion 7 M12

FDA Device
Class I
ongoing
Published 2025-02-26

On 2025-02-26 the FDA classified a Class I recall of Azurion 7 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-1159-2025
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 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (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) 722078, (2) 722223, (3) 722233 (OUS ONLY); UDI-DI: (1) 00884838085251, (2) 00884838099241, (3) 008… Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY); UDI-DI: (1) 00884838085251, (2) 00884838099241, (3) 00884838116764; Serial Numbers: (1) 465, 437, 438, 143, 302, 559, 170, 824, 626, 697, 278, 491, 215, 720, 612, 788, 141, 644, 279, 402, 290, 524, 415, 890, 412, 166, 136, 539, 532, 538, 291, 483, 497, 576, 500, 379, 753, 677, 709, 649, 441, 305, 289, 22, 257, 258, 187, 803, 399, 613, 121, 396, 536, 537, 488, 566, 833, 456, 478, 479, 224, 309, 719, 163, 921, 296, 364, 684, 239, 383, 249, 125, 829, 513, 376, 627, 725, 728, 611, 308, 522, 862, 1007, 661, 298, 571, 654, 656, 657, 658, 292, 844, 876, 480, 481, 410, 271, 493, 327, 550, 723, 269, 185, 902, 445, 360, 232, 425, 635, 546, 748, 294, 906, 603, 645, 870, 544, 545, 523, 520, 521, 556, 557, 558, 293, 840, 598, 384, 317, 535, 359, 700, 251, 786, 240, 256, 436, 585, 31, 165, 247, 733, 204, 205, 206, 888, 923, 195, 197, 162, 517, 218, 797, 444, 489, 222, 361, 362, 977, 30, 579, 223, 584, 618, 909, 193, 280, 962, 893, 287,

code_info

Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY); UDI-DI: (1) 00884838085251, (2) 00884838099241, (3) 008…

Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY); UDI-DI: (1) 00884838085251, (2) 00884838099241, (3) 00884838116764; Serial Numbers: (1) 465, 437, 438, 143, 302, 559, 170, 824, 626, 697, 278, 491, 215, 720, 612, 788, 141, 644, 279, 402, 290, 524, 415, 890, 412, 166, 136, 539, 532, 538, 291, 483, 497, 576, 500, 379, 753, 677, 709, 649, 441, 305, 289, 22, 257, 258, 187, 803, 399, 613, 121, 396, 536, 537, 488, 566, 833, 456, 478, 479, 224, 309, 719, 163, 921, 296, 364, 684, 239, 383, 249, 125, 829, 513, 376, 627, 725, 728, 611, 308, 522, 862, 1007, 661, 298, 571, 654, 656, 657, 658, 292, 844, 876, 480, 481, 410, 271, 493, 327, 550, 723, 269, 185, 902, 445, 360, 232, 425, 635, 546, 748, 294, 906, 603, 645, 870, 544, 545, 523, 520, 521, 556, 557, 558, 293, 840, 598, 384, 317, 535, 359, 700, 251, 786, 240, 256, 436, 585, 31, 165, 247, 733, 204, 205, 206, 888, 923, 195, 197, 162, 517, 218, 797, 444, 489, 222, 361, 362, 977, 30, 579, 223, 584, 618, 909, 193, 280, 962, 893, 287,

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-1159-2025%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.