FDA Device recall Z-1160-2025

Azurion 7 M20

FDA Device
Class I
ongoing
Published 2025-02-26

On 2025-02-26 the FDA classified a Class I recall of Azurion 7 M20 by Philips Medical Systems Nederland B V, citing possibility of the patient falling from the table related to the mattress used on the patient table.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1160-2025
Classification	Class I
Status	ongoing
Initiated	2025-01-13
Published	2025-02-26
Last updated	2026-09-13 11:57 UTC
Company	Philips Medical Systems Nederland B V
Distribution	US

Product

Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

Reason

Possibility of the patient falling from the table related to the mattress used on the patient table.

Identifiers

code_info	Catalog numbers: (1) 722079, (2) 722224, (3) 722234; UDI-DI: (1) 00884838085268, (2) 00884838099258, (3) 00884838116771… Catalog numbers: (1) 722079, (2) 722224, (3) 722234; UDI-DI: (1) 00884838085268, (2) 00884838099258, (3) 00884838116771; Serial Numbers: (1) 942, 948, 702, 703455, 703457, 703465, 703904, 45, 1316, 709, 710, 711, 713, 60, 213, 1297, 1399, 1369, 703309, 1238, 703416, 1042, 715, 703368, 703562, 703335, 465, 674, 753, 730, 703497, 804, 703413, 1142, 1410, 703329, 1090, 439, 526, 1379, 899, 327, 637, 455, 653, 593, 1018, 898, 1040, 497, 900, 1164, 334, 1063, 792, 919, 1157, 595, 250, 1246, 703532, 737, 703409, 703419, 628, 703861, 1171, 599, 320, 429, 1393, 605, 895, 540, 998, 29, 1201, 704281, 361, 769, 938, 801, 1023, 668, 1283, 703332, 423, 671, 793, 480, 937, 1048, 1137, 1424, 580, 581, 1352, 1412, 460, 1387, 923, 981, 499, 703486, 64, 703383, 703510, 708, 703334, 496, 887, 903, 422, 758, 1267, 703558, 633, 999, 1041, 703324, 374, 459, 747, 1107, 703435, 528, 50, 246, 78, 703584, 520, 738, 703350, 351, 1189, 1401, 954, 436, 1103, 691, 992, 820, 32, 296, 267, 403, 48, 1411, 1370, 703395

code_info

Catalog numbers: (1) 722079, (2) 722224, (3) 722234; UDI-DI: (1) 00884838085268, (2) 00884838099258, (3) 00884838116771…

Catalog numbers: (1) 722079, (2) 722224, (3) 722234; UDI-DI: (1) 00884838085268, (2) 00884838099258, (3) 00884838116771; Serial Numbers: (1) 942, 948, 702, 703455, 703457, 703465, 703904, 45, 1316, 709, 710, 711, 713, 60, 213, 1297, 1399, 1369, 703309, 1238, 703416, 1042, 715, 703368, 703562, 703335, 465, 674, 753, 730, 703497, 804, 703413, 1142, 1410, 703329, 1090, 439, 526, 1379, 899, 327, 637, 455, 653, 593, 1018, 898, 1040, 497, 900, 1164, 334, 1063, 792, 919, 1157, 595, 250, 1246, 703532, 737, 703409, 703419, 628, 703861, 1171, 599, 320, 429, 1393, 605, 895, 540, 998, 29, 1201, 704281, 361, 769, 938, 801, 1023, 668, 1283, 703332, 423, 671, 793, 480, 937, 1048, 1137, 1424, 580, 581, 1352, 1412, 460, 1387, 923, 981, 499, 703486, 64, 703383, 703510, 708, 703334, 496, 887, 903, 422, 758, 1267, 703558, 633, 999, 1041, 703324, 374, 459, 747, 1107, 703435, 528, 50, 246, 78, 703584, 520, 738, 703350, 351, 1189, 1401, 954, 436, 1103, 691, 992, 820, 32, 296, 267, 403, 48, 1411, 1370, 703395

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1160-2025%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.