FDA Device recall Z-1675-2026

Azurion 7 B12

FDA Device
Class II
ongoing
Published 2026-04-08

On 2026-04-08 the FDA classified a Class II recall of Azurion 7 B12 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-1675-2026
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 B12; System Code: (1)722067, (2)722225, (3)722235;

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: 722067; UDI: 00884838085350; System Serial Number: 221, 42, 172, 173, 109, 250, 103, 192, 92, 114, 225… (1) System Code: 722067; UDI: 00884838085350; System Serial Number: 221, 42, 172, 173, 109, 250, 103, 192, 92, 114, 225, 69, 214, 41, 98, 81, 123, 278, 46, 277, 115, 150, 163, 131, 71, 104, 132, 147, 208, 244, 75, 36, 234, 141, 70, 26, 148, 133, 57, 128, 188, 151, 68, 233, 111, 255, 43, 33, 22, 146, 256, 270, 238, 187, 74, 154, 157, 251, 237, 222, 95, 53, 262, 29, 59, 209, 260, 191, 274, 52, 107, 218, 169, 231, 142, 143, 144, 275, 127, 210, 211, 212, 213, 206, 30, 23, 265, 190, 268, 203, 138, 34, 113, 254, 140, 266, 60, 97, 45, 112, 134, 100, 101, 168, 235, 272, 58, 47, 273, 176, 64, 156, 276, 232, 54, 55, 165, 25, 271, 35, 202, 149, 243, 32, 224, 207, 76, 108, 226, 48, 264, 102, 84, 105, 99, 21, 159, 49, 185, 51, 239, 40, 94, 63, 96, 129, 245, 186, 130, 252, 161, 120, 170, 195, 196, 197, 171, 200, 193, 80, 28, 229, 145, 79, 93, 137, 50, 44, 38, 175, 227, 167, 78, 86, 91, 189, 198, 37, 72, 199, 88, 27, 121, 179, 183, 117, 118, 85, 89, 90, 119, 87, 31, 110, 178, 73, 194, 39, 56, 139, 61

code_info

(1) System Code: 722067; UDI: 00884838085350; System Serial Number: 221, 42, 172, 173, 109, 250, 103, 192, 92, 114, 225…

(1) System Code: 722067; UDI: 00884838085350; System Serial Number: 221, 42, 172, 173, 109, 250, 103, 192, 92, 114, 225, 69, 214, 41, 98, 81, 123, 278, 46, 277, 115, 150, 163, 131, 71, 104, 132, 147, 208, 244, 75, 36, 234, 141, 70, 26, 148, 133, 57, 128, 188, 151, 68, 233, 111, 255, 43, 33, 22, 146, 256, 270, 238, 187, 74, 154, 157, 251, 237, 222, 95, 53, 262, 29, 59, 209, 260, 191, 274, 52, 107, 218, 169, 231, 142, 143, 144, 275, 127, 210, 211, 212, 213, 206, 30, 23, 265, 190, 268, 203, 138, 34, 113, 254, 140, 266, 60, 97, 45, 112, 134, 100, 101, 168, 235, 272, 58, 47, 273, 176, 64, 156, 276, 232, 54, 55, 165, 25, 271, 35, 202, 149, 243, 32, 224, 207, 76, 108, 226, 48, 264, 102, 84, 105, 99, 21, 159, 49, 185, 51, 239, 40, 94, 63, 96, 129, 245, 186, 130, 252, 161, 120, 170, 195, 196, 197, 171, 200, 193, 80, 28, 229, 145, 79, 93, 137, 50, 44, 38, 175, 227, 167, 78, 86, 91, 189, 198, 37, 72, 199, 88, 27, 121, 179, 183, 117, 118, 85, 89, 90, 119, 87, 31, 110, 178, 73, 194, 39, 56, 139, 61

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-1675-2026%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.