FDA Device recall Z-2206-2025

Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103

FDA Device
Class II
ongoing
Published 2025-08-06

On 2025-08-06 the FDA classified a Class II recall of Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103 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-2206-2025
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 Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;

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) 781342, (2) 781377, (3) 782103; UDI-DI: (1) 00884838055339, (2) 00884838009813, (3) 0088483809… Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103; UDI-DI: (1) 00884838055339, (2) 00884838009813, (3) 00884838098299; Serial Numbers: (1) 71001, 71002, 71003, 71004, 71006, 71007, 71008, 71010, 71011, 71012, 71013, 71014, 71016, 71018, 71020, 71022, 71023, 71026, 71027, 71029, 71031, 71035, 71037, 71038, 71039, 71040, 71045, 71047, 71051, 71055, 71056, 71058, 71060, 71061, 71062, 71064, 71065, 71068, 71070, 71071, 71072, 71073, 71074, 71077, 71078, 71081, 71084, 71086, 71087, 71088, 71089, 71093, 71095, 71097, 71101, 71106, 71107, 71150, 71152, 71153, 71154, 71155, 71156, 71157, 71159, 71162, 71163, 71164, 71165, 71166, 71168, 71170, 71172, 71173, 71174, 71175, 71176, 71177, 71179, 71181, 71183, 71184, 71185, 71187, 71188, 71189, 71190, 71192, 71193, 71194, 71195, 71197, 71198, 71200, 71203, 71204, 71208, 71210, 71211, 71213, 71214, 71215, 71216, 71220, 71224, 71225, 71227, 71228, 71231, 71252, 71260, 71262, 71263, 71266, 71267, 71268, 71269, 71270, 71271, 71272, 71275, 71276, 7

code_info

Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103; UDI-DI: (1) 00884838055339, (2) 00884838009813, (3) 0088483809…

Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103; UDI-DI: (1) 00884838055339, (2) 00884838009813, (3) 00884838098299; Serial Numbers: (1) 71001, 71002, 71003, 71004, 71006, 71007, 71008, 71010, 71011, 71012, 71013, 71014, 71016, 71018, 71020, 71022, 71023, 71026, 71027, 71029, 71031, 71035, 71037, 71038, 71039, 71040, 71045, 71047, 71051, 71055, 71056, 71058, 71060, 71061, 71062, 71064, 71065, 71068, 71070, 71071, 71072, 71073, 71074, 71077, 71078, 71081, 71084, 71086, 71087, 71088, 71089, 71093, 71095, 71097, 71101, 71106, 71107, 71150, 71152, 71153, 71154, 71155, 71156, 71157, 71159, 71162, 71163, 71164, 71165, 71166, 71168, 71170, 71172, 71173, 71174, 71175, 71176, 71177, 71179, 71181, 71183, 71184, 71185, 71187, 71188, 71189, 71190, 71192, 71193, 71194, 71195, 71197, 71198, 71200, 71203, 71204, 71208, 71210, 71211, 71213, 71214, 71215, 71216, 71220, 71224, 71225, 71227, 71228, 71231, 71252, 71260, 71262, 71263, 71266, 71267, 71268, 71269, 71270, 71271, 71272, 71275, 71276, 7

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-2206-2025%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.