FDA Device recall Z-2204-2025

Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140

FDA Device
Class II
ongoing
Published 2025-08-06

On 2025-08-06 the FDA classified a Class II recall of Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140 by Philips North America, citing the potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2204-2025
Classification	Class II
Status	ongoing
Initiated	2025-06-30
Published	2025-08-06
Last updated	2026-09-13 11:57 UTC
Company	Philips North America
Distribution	US

Product

Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;

Reason

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.

Identifiers

code_info	Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140; UDI-DI: (1) 00884838099715… Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140; UDI-DI: (1) 00884838099715, (2) 00884838055322, (3) 00884838009820, (4) 00884838098275, (5) 00884838099043, (6) 00884838108646; Serial Numbers: (1) 61000, 61001, 61002, 61003, 61004, 61005, 61006, 61007, 61008, 61009, 61011, 61013, 61014, 61015, 61016, 61017, 61018, 61019, 61020, 61022, 61023, 61024, 61025, 61026, 61027, 61028, 61029, 61030, 61031, 61032, 61033, 61034, 61035, 61036, 61037, 61038, 61039, 61040, 61041, 61042, 61043, 61044, 61045, 61046, 61047, 61049, 61050, 61051, 61052, 61053, 61054, 61055, 61056, 61057, 61058, 61059, 61060, 61061, 61062, 61063, 61064, 61065, 61066, 61067, 61068, 61069, 61070, 61072, 61073, 61074, 61075, 61076, 61078, 61079, 61080, 61082, 61084, 61085, 61087, 61088, 61091, 61092, 61093, 61094, 61095, 61096, 61097, 61101, 61102, 61103, 61105, 61106, 61107, 61108, 61109, 61112, 61114, 61115, 61116, 61117, 61119, 61123, 61124, 61125, 61126, 61129, 61130, 61131, 611

code_info

Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140; UDI-DI: (1) 00884838099715…

Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140; UDI-DI: (1) 00884838099715, (2) 00884838055322, (3) 00884838009820, (4) 00884838098275, (5) 00884838099043, (6) 00884838108646; Serial Numbers: (1) 61000, 61001, 61002, 61003, 61004, 61005, 61006, 61007, 61008, 61009, 61011, 61013, 61014, 61015, 61016, 61017, 61018, 61019, 61020, 61022, 61023, 61024, 61025, 61026, 61027, 61028, 61029, 61030, 61031, 61032, 61033, 61034, 61035, 61036, 61037, 61038, 61039, 61040, 61041, 61042, 61043, 61044, 61045, 61046, 61047, 61049, 61050, 61051, 61052, 61053, 61054, 61055, 61056, 61057, 61058, 61059, 61060, 61061, 61062, 61063, 61064, 61065, 61066, 61067, 61068, 61069, 61070, 61072, 61073, 61074, 61075, 61076, 61078, 61079, 61080, 61082, 61084, 61085, 61087, 61088, 61091, 61092, 61093, 61094, 61095, 61096, 61097, 61101, 61102, 61103, 61105, 61106, 61107, 61108, 61109, 61112, 61114, 61115, 61116, 61117, 61119, 61123, 61124, 61125, 61126, 61129, 61130, 61131, 611

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-2204-2025%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.