FDA Device recall Z-2205-2025

Ingenia 1.5T S Model Number (REF): 781347

FDA Device
Class II
ongoing
Published 2025-08-06

On 2025-08-06 the FDA classified a Class II recall of Ingenia 1.5T S Model Number (REF): 781347 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-2205-2025
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 S Model Number (REF): 781347;

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 Number (REF): 781347; UDI-DI: 00884838068421; Serial Numbers: 81001, 81003, 81004, 81005, 81006, 81007, 81008, 81… Model Number (REF): 781347; UDI-DI: 00884838068421; Serial Numbers: 81001, 81003, 81004, 81005, 81006, 81007, 81008, 81009, 81010, 81011, 81013, 81014, 81015, 81016, 81017, 81018, 81019, 81020, 81023, 81024, 81025, 81027, 81028, 81029, 81030, 81031, 81032, 81033, 81034, 81035, 81037, 81038, 81040, 81041, 81042, 81043, 81044, 81045, 81046, 81047, 81048, 81049, 81050, 81051, 81052, 81055, 81056, 81058, 81059, 81060, 81061, 81062, 81063, 81064, 81065, 81067, 81070, 81071, 81072, 81074, 81075, 81076, 81077, 81078, 81079, 81080, 81084, 81085, 81086, 81087, 81088, 81090, 81091, 81092, 81093, 81094, 81095, 81096, 81097, 81098, 81103, 81105, 81106, 81108, 81111, 81112, 81113, 81114, 81115, 81116, 81117, 81118, 81122, 81123, 81124, 81126, 81127, 81128, 81129, 81131, 81132, 81133, 81137, 81138, 81139, 81140, 81145, 81146, 81147, 81148, 81149, 81151, 81152, 81153, 81154, 81155, 81156, 81157, 81158, 81159, 81162, 81164, 81165, 81167, 81170, 81171, 81172, 81173, 81174, 81175, 81176, 81178, 81179, 8

code_info

Model Number (REF): 781347; UDI-DI: 00884838068421; Serial Numbers: 81001, 81003, 81004, 81005, 81006, 81007, 81008, 81…

Model Number (REF): 781347; UDI-DI: 00884838068421; Serial Numbers: 81001, 81003, 81004, 81005, 81006, 81007, 81008, 81009, 81010, 81011, 81013, 81014, 81015, 81016, 81017, 81018, 81019, 81020, 81023, 81024, 81025, 81027, 81028, 81029, 81030, 81031, 81032, 81033, 81034, 81035, 81037, 81038, 81040, 81041, 81042, 81043, 81044, 81045, 81046, 81047, 81048, 81049, 81050, 81051, 81052, 81055, 81056, 81058, 81059, 81060, 81061, 81062, 81063, 81064, 81065, 81067, 81070, 81071, 81072, 81074, 81075, 81076, 81077, 81078, 81079, 81080, 81084, 81085, 81086, 81087, 81088, 81090, 81091, 81092, 81093, 81094, 81095, 81096, 81097, 81098, 81103, 81105, 81106, 81108, 81111, 81112, 81113, 81114, 81115, 81116, 81117, 81118, 81122, 81123, 81124, 81126, 81127, 81128, 81129, 81131, 81132, 81133, 81137, 81138, 81139, 81140, 81145, 81146, 81147, 81148, 81149, 81151, 81152, 81153, 81154, 81155, 81156, 81157, 81158, 81159, 81162, 81164, 81165, 81167, 81170, 81171, 81172, 81173, 81174, 81175, 81176, 81178, 81179, 8

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-2205-2025%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.