FDA Device recall Z-1113-2026

Philips Azurion system

FDA Device
Class II
ongoing
Published 2026-01-28

On 2026-01-28 the FDA classified a Class II recall of Philips Azurion system by Philips Medical Systems Nederland B V, citing philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrec….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1113-2026
Classification	Class II
Status	ongoing
Initiated	2025-12-12
Published	2026-01-28
Last updated	2026-09-13 11:58 UTC
Company	Philips Medical Systems Nederland B V
Distribution	AR, AZ, CO, DE, ID, IL, IN, MA, MO

Product

Philips Azurion system; Software Version Number: R3.1;

Reason

Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content and/or loss of data. Issue 1 - System remains in continuous restart mode after the start-up. Issue 2 - Longitudinal Position Error Applicable only to systems with Poly-G3 frontal stand.

Identifiers

code_info	Software Version Number: R3.1; (1) Model Number: 722221; System Product Name: Azurion 3 M12; UDI-DI: 00884838099203; S… Software Version Number: R3.1; (1) Model Number: 722221; System Product Name: Azurion 3 M12; UDI-DI: 00884838099203; Serial Numbers: (2) Model Number: 722222; System Product Name: Azurion 3 M15; UDI-DI: 00884838099210; Serial Numbers: (3) Model Number: 722223; System Product Name: Azurion 7 M12; UDI-DI: 00884838099241; Serial Numbers: (4) Model Number: 722224; System Product Name: Azurion 7 M20; UDI-DI: 00884838099258; Serial Numbers: (5) Model Number: 722225; System Product Name: Azurion 7 B12; UDI-DI: 00884838099265; Serial Numbers: (6) Model Number: 722226; System Product Name: Azurion 7 B20; UDI-DI: 00884838099272; Serial Numbers: (7) Model Number: 722227; System Product Name: Azurion 5 M12; UDI-DI: 00884838099227; Serial Numbers: (8) Model Number: 722228; System Product Name: Azurion 5 M20; UDI-DI: 00884838099234; Serial Numbers: (9) Model Number: 722229; System Product Name: Azurion 3 M12; UDI-DI: 00884838116726; Serial Numbers: 5, 9, 32, 40, 35, 31, 33; (10) Model Num

code_info

Software Version Number: R3.1; (1) Model Number: 722221; System Product Name: Azurion 3 M12; UDI-DI: 00884838099203; S…

Software Version Number: R3.1; (1) Model Number: 722221; System Product Name: Azurion 3 M12; UDI-DI: 00884838099203; Serial Numbers: (2) Model Number: 722222; System Product Name: Azurion 3 M15; UDI-DI: 00884838099210; Serial Numbers: (3) Model Number: 722223; System Product Name: Azurion 7 M12; UDI-DI: 00884838099241; Serial Numbers: (4) Model Number: 722224; System Product Name: Azurion 7 M20; UDI-DI: 00884838099258; Serial Numbers: (5) Model Number: 722225; System Product Name: Azurion 7 B12; UDI-DI: 00884838099265; Serial Numbers: (6) Model Number: 722226; System Product Name: Azurion 7 B20; UDI-DI: 00884838099272; Serial Numbers: (7) Model Number: 722227; System Product Name: Azurion 5 M12; UDI-DI: 00884838099227; Serial Numbers: (8) Model Number: 722228; System Product Name: Azurion 5 M20; UDI-DI: 00884838099234; Serial Numbers: (9) Model Number: 722229; System Product Name: Azurion 3 M12; UDI-DI: 00884838116726; Serial Numbers: 5, 9, 32, 40, 35, 31, 33; (10) Model Num

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-1113-2026%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.