FDA Device recall Z-2210-2025

Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY)

FDA Device
Class II
ongoing
Published 2025-08-06

On 2025-08-06 the FDA classified a Class II recall of Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY) 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-2210-2025
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 Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);

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) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY); UDI-DI: (1) 00884838088108, (2) 00884… Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY); UDI-DI: (1) 00884838088108, (2) 00884838098329, (3) 00884838108615, (4) None; Serial Numbers: (1) 46001, 46002, 46003, 46004, 46005, 46007, 46008, 46011, 46012, 46013, 46014, 46015, 46016, 46017, 46018, 46019, 46020, 46021, 46023, 46024, 46025, 46026, 46027, 46029, 46030, 46031, 46032, 46033, 46036, 46037, 46039, 46041, 46042, 46044, 46045, 46046, 46048, 46049, 46050, 46052, 46053, 46054, 46055, 46057, 46058, 46059, 46060, 46061, 46065, 46066, 46067, 46068, 46069, 46071, 46075, 46076, 46077, 46078, 46081, 46082, 46083, 46085, 46086, 46088, 46089, 46092, 46093, 46094, 46095, 46097, 46101, 46104, 46107, 46109, 46111, 46119, 46121, (2) 46200, 46201, 46202, 46203, 46204, 46205, 46206, 46207, 46208, 46209, 46211, 46212, 46213, 46214, 46215, 46217, 46218, 46219, 46220, 46222, 46224, 46225, 46226, 46228, 46231, 46233, 46234, 46235, 46237, 46239, 46240, 46241, 46242, 46243, 46245, 46247, 46249, 46250, 46258,

code_info

Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY); UDI-DI: (1) 00884838088108, (2) 00884…

Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY); UDI-DI: (1) 00884838088108, (2) 00884838098329, (3) 00884838108615, (4) None; Serial Numbers: (1) 46001, 46002, 46003, 46004, 46005, 46007, 46008, 46011, 46012, 46013, 46014, 46015, 46016, 46017, 46018, 46019, 46020, 46021, 46023, 46024, 46025, 46026, 46027, 46029, 46030, 46031, 46032, 46033, 46036, 46037, 46039, 46041, 46042, 46044, 46045, 46046, 46048, 46049, 46050, 46052, 46053, 46054, 46055, 46057, 46058, 46059, 46060, 46061, 46065, 46066, 46067, 46068, 46069, 46071, 46075, 46076, 46077, 46078, 46081, 46082, 46083, 46085, 46086, 46088, 46089, 46092, 46093, 46094, 46095, 46097, 46101, 46104, 46107, 46109, 46111, 46119, 46121, (2) 46200, 46201, 46202, 46203, 46204, 46205, 46206, 46207, 46208, 46209, 46211, 46212, 46213, 46214, 46215, 46217, 46218, 46219, 46220, 46222, 46224, 46225, 46226, 46228, 46231, 46233, 46234, 46235, 46237, 46239, 46240, 46241, 46242, 46243, 46245, 46247, 46249, 46250, 46258,

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-2210-2025%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.