FDA Device recall Z-2214-2025

MR 7700 Model Numbers (REF): (1) 782120, (2) 782153

FDA Device
Class II
ongoing
Published 2025-08-06

On 2025-08-06 the FDA classified a Class II recall of MR 7700 Model Numbers (REF): (1) 782120, (2) 782153 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-2214-2025
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 7700 Model Numbers (REF): (1) 782120, (2) 782153;

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) 782120, (2) 782153; UDI-DI: (1) 00884838104112, (2) 00884838112858; Serial Numbers: (1) 65000,… Model Numbers (REF): (1) 782120, (2) 782153; UDI-DI: (1) 00884838104112, (2) 00884838112858; Serial Numbers: (1) 65000, 65001, 65002, 65003, 65004, 65005, 65006, 65007, 65008, 65009, 65011, 65012, 65013, 65014, 65015, 65016, 65017, 65018, 65019, 65020, 65021, 65023, 65024, 65025, 65026, 65027, 65028, 65029, 65030, 65031, 65032, 65034, 65035, 65037, 65038, 65039, 65040, 65041, 65042, 65043, 65049, 65050, 65051, 65056, 65057, 65059, 65060, 65061, 65063, 65064, 65065, 65066, 65067, (2) 68000, 68001, 68006, 68007, 68008, 68009, 68010, 68011, 68012, 68013, 68014, 68015, 68016, 68017, 68018, 68020, 68022, 68023, 68024, 68025, 68028, 68029, 68030, 68031, 68033, 68034, 68036, 68037, 68041;

code_info

Model Numbers (REF): (1) 782120, (2) 782153; UDI-DI: (1) 00884838104112, (2) 00884838112858; Serial Numbers: (1) 65000,…

Model Numbers (REF): (1) 782120, (2) 782153; UDI-DI: (1) 00884838104112, (2) 00884838112858; Serial Numbers: (1) 65000, 65001, 65002, 65003, 65004, 65005, 65006, 65007, 65008, 65009, 65011, 65012, 65013, 65014, 65015, 65016, 65017, 65018, 65019, 65020, 65021, 65023, 65024, 65025, 65026, 65027, 65028, 65029, 65030, 65031, 65032, 65034, 65035, 65037, 65038, 65039, 65040, 65041, 65042, 65043, 65049, 65050, 65051, 65056, 65057, 65059, 65060, 65061, 65063, 65064, 65065, 65066, 65067, (2) 68000, 68001, 68006, 68007, 68008, 68009, 68010, 68011, 68012, 68013, 68014, 68015, 68016, 68017, 68018, 68020, 68022, 68023, 68024, 68025, 68028, 68029, 68030, 68031, 68033, 68034, 68036, 68037, 68041;

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-2214-2025%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.