FDA Device recall Z-1680-2026

Azurion 5 M20

FDA Device
Class II
ongoing
Published 2026-04-08

On 2026-04-08 the FDA classified a Class II recall of Azurion 5 M20 by Philips Medical Systems Nederland B V, citing philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1680-2026
Classification	Class II
Status	ongoing
Initiated	2026-03-03
Published	2026-04-08
Last updated	2026-09-13 11:58 UTC
Company	Philips Medical Systems Nederland B V
Distribution	US

Product

Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);

Reason

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Identifiers

code_info	(1) System Code: 722228; UDI: 00884838099234; System Serial Number: 67, 524, 49, 678, 679, 10, 36, 64, 110, 403, 328, 4… (1) System Code: 722228; UDI: 00884838099234; System Serial Number: 67, 524, 49, 678, 679, 10, 36, 64, 110, 403, 328, 481, 373, 149, 213, 45, 537, 615, 159, 18, 231, 180, 61, 204, 273, 538, 76, 502, 150, 132, 399, 533, 211, 17, 47, 38, 87, 617, 618, 619, 128, 522, 32, 600, 23, 25, 62, 177, 181, 48, 189, 153, 79, 80, 157, 24, 187, 26, 642, 431, 29, 113, 122, 127, 6, 123, 124, 185, 186, 198, 92, 215, 573, 91, 529, 523, 205, 20, 37, 659, 145, 3, 567, 539, 645, 156, 308, 333, 335, 570, 560, 44, 569, 418, 525, 280, 616, 387, 568, 471, 428, 465, 556, 629, 102, 103, 176, 178, 109, 16, 299, 234, 566, 508, 571, 463, 71, 493, 1, 434, 647, 317, 562, 230, 293, 552, 457, 458, 369, 561, 517, 203, 554, 260, 100, 101, 107, 108, 640, 99, 318, 21, 22, 676, 677, 154, 531, 75, 602, 78, 574, 158, 461, 370, 613, 393, 564, 482, 194, 660, 673, 60, 464, 4, 462, 138, 223, 312, 319, 98, 623, 475, 125, 218, 513, 442, 435, 9, 95, 557, 174, 548, 486, 487, 84, 454, 346, 396, 39, 339, 172, 191, 327, 52, 575, 196, 406

code_info

(1) System Code: 722228; UDI: 00884838099234; System Serial Number: 67, 524, 49, 678, 679, 10, 36, 64, 110, 403, 328, 4…

(1) System Code: 722228; UDI: 00884838099234; System Serial Number: 67, 524, 49, 678, 679, 10, 36, 64, 110, 403, 328, 481, 373, 149, 213, 45, 537, 615, 159, 18, 231, 180, 61, 204, 273, 538, 76, 502, 150, 132, 399, 533, 211, 17, 47, 38, 87, 617, 618, 619, 128, 522, 32, 600, 23, 25, 62, 177, 181, 48, 189, 153, 79, 80, 157, 24, 187, 26, 642, 431, 29, 113, 122, 127, 6, 123, 124, 185, 186, 198, 92, 215, 573, 91, 529, 523, 205, 20, 37, 659, 145, 3, 567, 539, 645, 156, 308, 333, 335, 570, 560, 44, 569, 418, 525, 280, 616, 387, 568, 471, 428, 465, 556, 629, 102, 103, 176, 178, 109, 16, 299, 234, 566, 508, 571, 463, 71, 493, 1, 434, 647, 317, 562, 230, 293, 552, 457, 458, 369, 561, 517, 203, 554, 260, 100, 101, 107, 108, 640, 99, 318, 21, 22, 676, 677, 154, 531, 75, 602, 78, 574, 158, 461, 370, 613, 393, 564, 482, 194, 660, 673, 60, 464, 4, 462, 138, 223, 312, 319, 98, 623, 475, 125, 218, 513, 442, 435, 9, 95, 557, 174, 548, 486, 487, 84, 454, 346, 396, 39, 339, 172, 191, 327, 52, 575, 196, 406

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1680-2026%22

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