FDA Device recall Z-2207-2025

Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105

FDA Device
Class II
ongoing
Published 2025-08-06

On 2025-08-06 the FDA classified a Class II recall of Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105 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-2207-2025
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 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;

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) 781271, (2) 782105; UDI-DI: (1) 00884838068452, (2) 00884838098312; Serial Numbers: (1) 78000,… Model Numbers (REF): (1) 781271, (2) 782105; UDI-DI: (1) 00884838068452, (2) 00884838098312; Serial Numbers: (1) 78000, 78003, 78004, 78005, 78007, 78008, 78009, 78010, 78011, 78012, 78013, 78014, 78015, 78016, 78017, 78018, 78019, 78021, 78022, 78023, 78025, 78026, 78027, 78028, 78029, 78030, 78031, 78032, 78033, 78034, 78035, 78036, 78038, 78039, 78040, 78042, 78043, 78044, 78045, 78046, 78047, 78048, 78049, 78050, 78051, 78053, 78058, 78059, 78060, 78062, 78063, 78064, 78065, 78066, 78067, 78068, 78070, 78071, 78072, 78073, 78074, 78075, 78076, 78077, 78081, 78082, 78083, 78084, 78086, 78087, 78088, 78089, 78091, 78092, 78095, 78096, 78097, 78098, 78099, 78100, 78101, 78102, 78103, 78104, 78106, 78107, 78109, 78110, 78111, 78112, 78113, 78114, 78115, 78117, 78118, 78120, 78121, 78122, 78123, 78126, 78127, 78128, 78129, 78132, 78133, 78135, 78137, 78138, 78139, 78140, 78141, 78142, 78145, 78147, 78148, 78149, 78150, 78151, 78154, 78155, 78156, 78157, 78158, 78161, 78162, 78164, 78166

code_info

Model Numbers (REF): (1) 781271, (2) 782105; UDI-DI: (1) 00884838068452, (2) 00884838098312; Serial Numbers: (1) 78000,…

Model Numbers (REF): (1) 781271, (2) 782105; UDI-DI: (1) 00884838068452, (2) 00884838098312; Serial Numbers: (1) 78000, 78003, 78004, 78005, 78007, 78008, 78009, 78010, 78011, 78012, 78013, 78014, 78015, 78016, 78017, 78018, 78019, 78021, 78022, 78023, 78025, 78026, 78027, 78028, 78029, 78030, 78031, 78032, 78033, 78034, 78035, 78036, 78038, 78039, 78040, 78042, 78043, 78044, 78045, 78046, 78047, 78048, 78049, 78050, 78051, 78053, 78058, 78059, 78060, 78062, 78063, 78064, 78065, 78066, 78067, 78068, 78070, 78071, 78072, 78073, 78074, 78075, 78076, 78077, 78081, 78082, 78083, 78084, 78086, 78087, 78088, 78089, 78091, 78092, 78095, 78096, 78097, 78098, 78099, 78100, 78101, 78102, 78103, 78104, 78106, 78107, 78109, 78110, 78111, 78112, 78113, 78114, 78115, 78117, 78118, 78120, 78121, 78122, 78123, 78126, 78127, 78128, 78129, 78132, 78133, 78135, 78137, 78138, 78139, 78140, 78141, 78142, 78145, 78147, 78148, 78149, 78150, 78151, 78154, 78155, 78156, 78157, 78158, 78161, 78162, 78164, 78166

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-2207-2025%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.