FDA Device recall Z-1673-2026

Azurion 3 M12

FDA Device
Class II
ongoing
Published 2026-04-08

On 2026-04-08 the FDA classified a Class II recall of Azurion 3 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-1673-2026
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 3 M12; System Code: (1)722063, (2)722221, (3)722229;

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: 722063; UDI: 00884838085275; System Serial Number:122, 56, 64, 131, 84, 132, 96, 98, 108, 77, 82, 145,… (1) System Code: 722063; UDI: 00884838085275; System Serial Number:122, 56, 64, 131, 84, 132, 96, 98, 108, 77, 82, 145, 47, 146, 80, 102, 43, 117, 2, 149, 99, 44, 3, 28, 144, 62, 119, 61, 22, 29, 153, 40, 70, 30, 25, 19, 120, 121, 110, 14, 16, 17, 53, 103, 127, 97, 143, 41, 104, 116, 151, 93, 141, 115, 137, 73, 150, 128, 105, 4, 50, 129, 72, 38, 21, 78, 23, 76, 63, 69, 59, 51, 92, 139, 130, 154, 75, 24, 94, 100, 54, 46, 26, 71, 106, 83, 36, 37, 27, 15, 135, 123, 107, 87, 85, 89, 88, 86, 90, 91, 79, 133, 81, 140, 52, 48, 148, 55, 113; (2) System Code: 722221; UDI: 00884838085275; System Serial Number:181, 3, 7, 178, 54, 6, 93, 69, 9, 115, 177, 85, 19, 49, 171, 153, 108, 193, 104, 169, 45, 101, 135, 106, 51, 114, 36, 124, 197, 129, 4, 154, 146, 68, 195, 130, 183, 187, 42, 172, 164, 190, 151, 71, 152, 184, 147, 32, 105, 182, 58, 103, 149, 127, 128, 86, 122, 60, 155, 66, 33, 55, 70, 123, 118, 61, 44, 185, 74, 95, 205, 13, 99, 34, 142, 39, 144, 82, 145, 59, 77, 180, 126, 97, 132, 79, 91, 1

code_info

(1) System Code: 722063; UDI: 00884838085275; System Serial Number:122, 56, 64, 131, 84, 132, 96, 98, 108, 77, 82, 145,…

(1) System Code: 722063; UDI: 00884838085275; System Serial Number:122, 56, 64, 131, 84, 132, 96, 98, 108, 77, 82, 145, 47, 146, 80, 102, 43, 117, 2, 149, 99, 44, 3, 28, 144, 62, 119, 61, 22, 29, 153, 40, 70, 30, 25, 19, 120, 121, 110, 14, 16, 17, 53, 103, 127, 97, 143, 41, 104, 116, 151, 93, 141, 115, 137, 73, 150, 128, 105, 4, 50, 129, 72, 38, 21, 78, 23, 76, 63, 69, 59, 51, 92, 139, 130, 154, 75, 24, 94, 100, 54, 46, 26, 71, 106, 83, 36, 37, 27, 15, 135, 123, 107, 87, 85, 89, 88, 86, 90, 91, 79, 133, 81, 140, 52, 48, 148, 55, 113; (2) System Code: 722221; UDI: 00884838085275; System Serial Number:181, 3, 7, 178, 54, 6, 93, 69, 9, 115, 177, 85, 19, 49, 171, 153, 108, 193, 104, 169, 45, 101, 135, 106, 51, 114, 36, 124, 197, 129, 4, 154, 146, 68, 195, 130, 183, 187, 42, 172, 164, 190, 151, 71, 152, 184, 147, 32, 105, 182, 58, 103, 149, 127, 128, 86, 122, 60, 155, 66, 33, 55, 70, 123, 118, 61, 44, 185, 74, 95, 205, 13, 99, 34, 142, 39, 144, 82, 145, 59, 77, 180, 126, 97, 132, 79, 91, 1

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-1673-2026%22

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