FDA Device recall Z-1677-2026

Azurion 7 M12

FDA Device
Class II
ongoing
Published 2026-04-08

On 2026-04-08 the FDA classified a Class II recall of Azurion 7 M12 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-1677-2026
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 7 M12; System Code: (1)722078, (2)722223, (3)722233;

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: 722078; UDI: 00884838085251; System Serial Number: 302, 585, 410, 753, 523, 293, 840, 291, 536, 537, 8… (1) System Code: 722078; UDI: 00884838085251; System Serial Number: 302, 585, 410, 753, 523, 293, 840, 291, 536, 537, 870, 613, 598, 679, 224, 829, 249, 546, 478, 479, 513, 278, 437, 438, 456, 566, 833, 488, 327, 550, 571, 544, 545, 465, 376, 31, 921, 700, 165, 445, 539, 654, 656, 657, 658, 436, 1007, 862, 786, 308, 396, 576, 121, 239, 383, 491, 125, 500, 645, 379, 399, 803, 415, 296, 136, 890, 626, 697, 559, 532, 538, 185, 166, 257, 258, 684, 359, 143, 661, 824, 649, 493, 720, 520, 521, 556, 557, 558, 187, 902, 269, 317, 522, 611, 677, 709, 535, 170, 723, 251, 298, 22, 305, 725, 728, 524, 290, 441, 384, 480, 481, 364, 294, 906, 240, 256, 603, 289, 719, 163, 215, 271, 788, 412, 627, 141, 644, 292, 844, 876, 748, 483, 497, 309, 232, 425, 635, 612, 797, 247, 733, 162, 517, 888, 923, 204, 205, 206, 195, 197, 218, 444, 986, 561, 503, 689, 499, 135, 589, 38, 977, 738, 476, 380, 453, 24, 690, 356, 343, 344, 174, 898, 482, 378, 764, 693, 694, 770, 771, 772, 773, 439, 191, 938, 980, 981, 982,

code_info

(1) System Code: 722078; UDI: 00884838085251; System Serial Number: 302, 585, 410, 753, 523, 293, 840, 291, 536, 537, 8…

(1) System Code: 722078; UDI: 00884838085251; System Serial Number: 302, 585, 410, 753, 523, 293, 840, 291, 536, 537, 870, 613, 598, 679, 224, 829, 249, 546, 478, 479, 513, 278, 437, 438, 456, 566, 833, 488, 327, 550, 571, 544, 545, 465, 376, 31, 921, 700, 165, 445, 539, 654, 656, 657, 658, 436, 1007, 862, 786, 308, 396, 576, 121, 239, 383, 491, 125, 500, 645, 379, 399, 803, 415, 296, 136, 890, 626, 697, 559, 532, 538, 185, 166, 257, 258, 684, 359, 143, 661, 824, 649, 493, 720, 520, 521, 556, 557, 558, 187, 902, 269, 317, 522, 611, 677, 709, 535, 170, 723, 251, 298, 22, 305, 725, 728, 524, 290, 441, 384, 480, 481, 364, 294, 906, 240, 256, 603, 289, 719, 163, 215, 271, 788, 412, 627, 141, 644, 292, 844, 876, 748, 483, 497, 309, 232, 425, 635, 612, 797, 247, 733, 162, 517, 888, 923, 204, 205, 206, 195, 197, 218, 444, 986, 561, 503, 689, 499, 135, 589, 38, 977, 738, 476, 380, 453, 24, 690, 356, 343, 344, 174, 898, 482, 378, 764, 693, 694, 770, 771, 772, 773, 439, 191, 938, 980, 981, 982,

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-1677-2026%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.