FDA Device recall Z-2213-2025

MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152

FDA Device
Class II
ongoing
Published 2025-08-06

On 2025-08-06 the FDA classified a Class II recall of MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152 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-2213-2025
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

MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;

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) 782110, (2) 782135, (3) 782152; UDI-DI: (1) 00884838099364, (2) None, (3) 00884838112841; Seri… Model Numbers (REF): (1) 782110, (2) 782135, (3) 782152; UDI-DI: (1) 00884838099364, (2) None, (3) 00884838112841; Serial Numbers: (1) 63000, 63001, 63006, 63007, 63008, 63009, 63010, 63011, 63012, 63013, 63014, 63015, 63016, 63018, 63019, 63021, 63022, 63023, 63024, 63025, 63026, 63027, 63028, 63029, 63030, 63031, 63032, 63033, 63034, 63035, 63036, 63038, 63039, 63041, 63042, 63043, 63044, 63046, 63047, 63049, 63050, 63051, 63053, 63054, 63057, 63058, 63059, 63060, 63062, 63063, 63064, 63066, 63067, 63068, 63069, 63070, 63071, 63072, 63074, 63075, 63076, 63078, 63079, 63080, 63082, 63083, 63084, 63085, 63086, 63087, 63090, 63091, 63092, 63093, 63094, 63095, 63096, 63097, 63098, 63099, 63100, 63103, 63104, 63105, 63106, 63107, 63108, 63109, 63110, 63111, 63112, 63113, 63115, 63116, 63119, 63121, 63122, 63123, 63125, 63126, 63127, 63128, 63130, 63132, 63134, 63135, 63136, 63137, 63138, 63139, 63140, 63141, 63142, 63143, 63144, 63146, 63148, 63149, 63150, 63151, 63152, 63153, 63154, 6315

code_info

Model Numbers (REF): (1) 782110, (2) 782135, (3) 782152; UDI-DI: (1) 00884838099364, (2) None, (3) 00884838112841; Seri…

Model Numbers (REF): (1) 782110, (2) 782135, (3) 782152; UDI-DI: (1) 00884838099364, (2) None, (3) 00884838112841; Serial Numbers: (1) 63000, 63001, 63006, 63007, 63008, 63009, 63010, 63011, 63012, 63013, 63014, 63015, 63016, 63018, 63019, 63021, 63022, 63023, 63024, 63025, 63026, 63027, 63028, 63029, 63030, 63031, 63032, 63033, 63034, 63035, 63036, 63038, 63039, 63041, 63042, 63043, 63044, 63046, 63047, 63049, 63050, 63051, 63053, 63054, 63057, 63058, 63059, 63060, 63062, 63063, 63064, 63066, 63067, 63068, 63069, 63070, 63071, 63072, 63074, 63075, 63076, 63078, 63079, 63080, 63082, 63083, 63084, 63085, 63086, 63087, 63090, 63091, 63092, 63093, 63094, 63095, 63096, 63097, 63098, 63099, 63100, 63103, 63104, 63105, 63106, 63107, 63108, 63109, 63110, 63111, 63112, 63113, 63115, 63116, 63119, 63121, 63122, 63123, 63125, 63126, 63127, 63128, 63130, 63132, 63134, 63135, 63136, 63137, 63138, 63139, 63140, 63141, 63142, 63143, 63144, 63146, 63148, 63149, 63150, 63151, 63152, 63153, 63154, 6315

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-2213-2025%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.