FDA Device recall Z-1158-2025

Azurion 7 B20

FDA Device
Class I
ongoing
Published 2025-02-26

On 2025-02-26 the FDA classified a Class I recall of Azurion 7 B20 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-1158-2025
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 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.

Reason

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

Identifiers

code_info	Catalog numbers: (1) 722068, (2) 722226, (3) 722236; UDI-DI: (1) 00884838085367, (2) 00884838099272, (3) 00884838116801… Catalog numbers: (1) 722068, (2) 722226, (3) 722236; UDI-DI: (1) 00884838085367, (2) 00884838099272, (3) 00884838116801; Serial Numbers: (1) 213, 407, 85, 89, 320, 73, 308, 288, 172, 295, 110, 406, 4444, 149, 350, 243, 143, 146, 109, 413, 137, 335, 270, 319, 95, 322, 324, 374, 170, 440, 184, 64, 373, 442, 431, 136, 279, 75, 251, 400, 271, 337, 329, 232, 261, 262, 477, 564, 354, 361, 443, 104, 114, 82, 490, 196, 370, 84, 107, 528, 247, 205, 42, 117, 469, 103, 520, 446, 78, 304, 153, 323, 457, 470, 472, 150, 277, 147, 547, 462, 479, 511, 285, 487, 101, 524, 282, 76, 510, 130, 356, 494, 178, 467, 505, 239, 225, 459, 265, 275, 485, 549, 534, 365, 314, 481, 77, 552, 44, 62, 158, 535, 453, 338, 399, 215, 37, 360, 36, 408, 420, 276, 68, 359, 584, 608, 563, 556, 557, 597, 601, 605, 553, 551, 516, 612, 614, 590, 540, 591, 617, 616, 599, 602, 570, 618, 574, 560, 609, 526, 559, 603, 600, 575, 593, 589, 624, 604, 372, 212, 475, 142, 97, 236, 237, 87, 53, 376, 111, 74, 394, 138, 185, 515, 162, 79,

code_info

Catalog numbers: (1) 722068, (2) 722226, (3) 722236; UDI-DI: (1) 00884838085367, (2) 00884838099272, (3) 00884838116801…

Catalog numbers: (1) 722068, (2) 722226, (3) 722236; UDI-DI: (1) 00884838085367, (2) 00884838099272, (3) 00884838116801; Serial Numbers: (1) 213, 407, 85, 89, 320, 73, 308, 288, 172, 295, 110, 406, 4444, 149, 350, 243, 143, 146, 109, 413, 137, 335, 270, 319, 95, 322, 324, 374, 170, 440, 184, 64, 373, 442, 431, 136, 279, 75, 251, 400, 271, 337, 329, 232, 261, 262, 477, 564, 354, 361, 443, 104, 114, 82, 490, 196, 370, 84, 107, 528, 247, 205, 42, 117, 469, 103, 520, 446, 78, 304, 153, 323, 457, 470, 472, 150, 277, 147, 547, 462, 479, 511, 285, 487, 101, 524, 282, 76, 510, 130, 356, 494, 178, 467, 505, 239, 225, 459, 265, 275, 485, 549, 534, 365, 314, 481, 77, 552, 44, 62, 158, 535, 453, 338, 399, 215, 37, 360, 36, 408, 420, 276, 68, 359, 584, 608, 563, 556, 557, 597, 601, 605, 553, 551, 516, 612, 614, 590, 540, 591, 617, 616, 599, 602, 570, 618, 574, 560, 609, 526, 559, 603, 600, 575, 593, 589, 624, 604, 372, 212, 475, 142, 97, 236, 237, 87, 53, 376, 111, 74, 394, 138, 185, 515, 162, 79,

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-1158-2025%22

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