FDA Device recall Z-1678-2026

Azurion 7 M20

FDA Device
Class II
ongoing
Published 2026-04-08

On 2026-04-08 the FDA classified a Class II recall of Azurion 7 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-1678-2026
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 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (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: 722079; UDI: 00884838085268; System Serial Number: 1023, 645, 646, 1013, 1387, 460, 35, 40, 43, 703307… (1) System Code: 722079; UDI: 00884838085268; System Serial Number: 1023, 645, 646, 1013, 1387, 460, 35, 40, 43, 703307, 703904, 1048, 1137, 401, 1010, 1054, 266, 534, 535, 536, 818, 412, 617, 246, 488, 53, 57, 905, 55, 691, 992, 809, 848, 1033, 836, 891, 1155, 466, 1157, 1395, 703559, 263, 420, 703391, 673, 297, 298, 299, 564, 838, 1032, 1117, 987, 1310, 1211, 1213, 47, 1365, 1408, 881, 774, 856, 922, 58, 471, 1012, 755, 633, 703540, 296, 703558, 574, 703336, 842, 884, 991, 753, 703493, 1086, 790, 840, 407, 408, 481, 703350, 877, 703395, 703323, 703775, 590, 709, 710, 711, 713, 716, 1216, 483, 1098, 1392, 241, 703408, 1108, 1363, 1355, 1414, 703387, 703404, 863, 350, 528, 703465, 1380, 908, 1238, 1378, 262, 598, 858, 859, 275, 703861, 520, 335, 1018, 593, 911, 480, 1410, 703329, 213, 325, 496, 887, 903, 703413, 1432, 594, 1309, 1312, 999, 1424, 465, 674, 1084, 353, 499, 1230, 813, 703508, 33, 1346, 1189, 1401, 361, 267, 403, 439, 526, 1021, 736, 1370, 608, 68, 703324, 611, 413, 414, 4

code_info

(1) System Code: 722079; UDI: 00884838085268; System Serial Number: 1023, 645, 646, 1013, 1387, 460, 35, 40, 43, 703307…

(1) System Code: 722079; UDI: 00884838085268; System Serial Number: 1023, 645, 646, 1013, 1387, 460, 35, 40, 43, 703307, 703904, 1048, 1137, 401, 1010, 1054, 266, 534, 535, 536, 818, 412, 617, 246, 488, 53, 57, 905, 55, 691, 992, 809, 848, 1033, 836, 891, 1155, 466, 1157, 1395, 703559, 263, 420, 703391, 673, 297, 298, 299, 564, 838, 1032, 1117, 987, 1310, 1211, 1213, 47, 1365, 1408, 881, 774, 856, 922, 58, 471, 1012, 755, 633, 703540, 296, 703558, 574, 703336, 842, 884, 991, 753, 703493, 1086, 790, 840, 407, 408, 481, 703350, 877, 703395, 703323, 703775, 590, 709, 710, 711, 713, 716, 1216, 483, 1098, 1392, 241, 703408, 1108, 1363, 1355, 1414, 703387, 703404, 863, 350, 528, 703465, 1380, 908, 1238, 1378, 262, 598, 858, 859, 275, 703861, 520, 335, 1018, 593, 911, 480, 1410, 703329, 213, 325, 496, 887, 903, 703413, 1432, 594, 1309, 1312, 999, 1424, 465, 674, 1084, 353, 499, 1230, 813, 703508, 33, 1346, 1189, 1401, 361, 267, 403, 439, 526, 1021, 736, 1370, 608, 68, 703324, 611, 413, 414, 4

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-1678-2026%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.