FDA Device recall Z-1679-2026

Azurion 5 M12

FDA Device
Class II
ongoing
Published 2026-04-08

On 2026-04-08 the FDA classified a Class II recall of Azurion 5 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-1679-2026
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 M12; System Code: (1)722227, (2)722231;

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: 722227; UDI: 00884838099227; System Serial Number: 265, 135, 88, 276, 264, 271, 63, 238, 360, 23, 127,… (1) System Code: 722227; UDI: 00884838099227; System Serial Number: 265, 135, 88, 276, 264, 271, 63, 238, 360, 23, 127, 159, 197, 149, 54, 56, 230, 192, 156, 250, 98, 31, 128, 81, 24, 37, 320, 179, 270, 151, 53, 246, 245, 84, 38, 28, 29, 170, 30, 338, 324, 108, 305, 168, 172, 356, 346, 62, 236, 25, 313, 339, 104, 321, 59, 109, 101, 19, 155, 99, 285, 247, 261, 298, 177, 138, 337, 157, 158, 228, 249, 61, 287, 55, 239, 306, 215, 336, 213, 76, 216, 73, 318, 353, 65, 167, 41, 85, 191, 20, 226, 102, 40, 87, 163, 83, 251, 268, 309, 310, 316, 290, 272, 5, 6, 7, 218, 36, 75, 195, 43, 345, 116, 18, 153, 351, 352, 14, 15, 120, 262, 204, 258, 326, 348, 17, 141, 114, 103, 355, 113, 110, 315, 21, 161, 194, 105, 173, 174, 64, 49, 71, 91, 187, 166, 210, 219, 222, 273, 205, 280, 300, 256, 335, 121, 80, 123, 243, 344, 308, 22, 140, 90, 142, 69, 200, 72, 362, 242, 323, 331, 136, 269, 137, 77, 89, 294, 181, 234, 95, 2, 111, 221, 293, 165, 342, 1, 12, 16, 257, 330, 67, 340, 260, 148, 281, 284, 248, 333, 19

code_info

(1) System Code: 722227; UDI: 00884838099227; System Serial Number: 265, 135, 88, 276, 264, 271, 63, 238, 360, 23, 127,…

(1) System Code: 722227; UDI: 00884838099227; System Serial Number: 265, 135, 88, 276, 264, 271, 63, 238, 360, 23, 127, 159, 197, 149, 54, 56, 230, 192, 156, 250, 98, 31, 128, 81, 24, 37, 320, 179, 270, 151, 53, 246, 245, 84, 38, 28, 29, 170, 30, 338, 324, 108, 305, 168, 172, 356, 346, 62, 236, 25, 313, 339, 104, 321, 59, 109, 101, 19, 155, 99, 285, 247, 261, 298, 177, 138, 337, 157, 158, 228, 249, 61, 287, 55, 239, 306, 215, 336, 213, 76, 216, 73, 318, 353, 65, 167, 41, 85, 191, 20, 226, 102, 40, 87, 163, 83, 251, 268, 309, 310, 316, 290, 272, 5, 6, 7, 218, 36, 75, 195, 43, 345, 116, 18, 153, 351, 352, 14, 15, 120, 262, 204, 258, 326, 348, 17, 141, 114, 103, 355, 113, 110, 315, 21, 161, 194, 105, 173, 174, 64, 49, 71, 91, 187, 166, 210, 219, 222, 273, 205, 280, 300, 256, 335, 121, 80, 123, 243, 344, 308, 22, 140, 90, 142, 69, 200, 72, 362, 242, 323, 331, 136, 269, 137, 77, 89, 294, 181, 234, 95, 2, 111, 221, 293, 165, 342, 1, 12, 16, 257, 330, 67, 340, 260, 148, 281, 284, 248, 333, 19

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-1679-2026%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.