FDA Device recall Z-2208-2025

Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139

FDA Device
Class II
ongoing
Published 2025-08-06

On 2025-08-06 the FDA classified a Class II recall of Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139 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-2208-2025
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 Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;

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) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139; UDI-DI: (1) 00884838090057, (2) 00884… Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139; UDI-DI: (1) 00884838090057, (2) 00884838098343, (3) None, (4) 00884838108639; Serial Numbers: (1) 48000, 48001, 48003, 48004, 48005, 48009, 48010, 48011, 48012, 48013, 48014, 48015, 48016, 48017, 48018, 48019, 48020, 48022, 48023, 48026, 48027, 48028, 48030, 48031, 48032, 48033, 48034, 48035, 48036, 48037, 48038, 48039, 48040, 48043, 48044, 48045, 48046, 48047, 48049, 48050, 48051, 48052, 48053, 48055, 48056, 48112, 48120, 48122, 48126, 48127, 48128, 48129, 48130, 48131, 48132, 48133, 48134, 48135, 48136, 48144, 48145, 48146, 48147, 48148, 48151, 48152, 48153, 48154, 48155, 48158, 48160, 48162, 48163, 48164, 48165, 48166, 48167, 48169, 48170, 48171, 48172, 48173, 48174, 48177, 48178, 48179, 48180, 48181, 48182, 48183, 48184, 48185, 48186, 48187, 48188, 48190, 48191, 48192, 48194, 48196, 48198, 48199, 48200, 48207, 48214, 48216, 48217, 48218, 48219, 48222, 48223, 48224, 48225, 48226, 48233, 48234, 48236, 4

code_info

Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139; UDI-DI: (1) 00884838090057, (2) 00884…

Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139; UDI-DI: (1) 00884838090057, (2) 00884838098343, (3) None, (4) 00884838108639; Serial Numbers: (1) 48000, 48001, 48003, 48004, 48005, 48009, 48010, 48011, 48012, 48013, 48014, 48015, 48016, 48017, 48018, 48019, 48020, 48022, 48023, 48026, 48027, 48028, 48030, 48031, 48032, 48033, 48034, 48035, 48036, 48037, 48038, 48039, 48040, 48043, 48044, 48045, 48046, 48047, 48049, 48050, 48051, 48052, 48053, 48055, 48056, 48112, 48120, 48122, 48126, 48127, 48128, 48129, 48130, 48131, 48132, 48133, 48134, 48135, 48136, 48144, 48145, 48146, 48147, 48148, 48151, 48152, 48153, 48154, 48155, 48158, 48160, 48162, 48163, 48164, 48165, 48166, 48167, 48169, 48170, 48171, 48172, 48173, 48174, 48177, 48178, 48179, 48180, 48181, 48182, 48183, 48184, 48185, 48186, 48187, 48188, 48190, 48191, 48192, 48194, 48196, 48198, 48199, 48200, 48207, 48214, 48216, 48217, 48218, 48219, 48222, 48223, 48224, 48225, 48226, 48233, 48234, 48236, 4

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-2208-2025%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.