FDA Device recall Z-2478-2024

Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1

FDA Device
Class II
ongoing
Published 2024-08-14

On 2024-08-14 the FDA classified a Class II recall of Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1 by Ge Medical Systems, citing GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the fol….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2478-2024
Classification	Class II
Status	ongoing
Initiated	2024-06-14
Published	2024-08-14
Last updated	2026-09-13 11:57 UTC
Company	Ge Medical Systems
Distribution	n/a

Product

Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

Reason

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Identifiers

code_info	System ID: 1009000, 201871MR, DZ1396MR01, DZ1820MR01, DZ1339MR02, DZ1339MR01, DZ1061MR01, DZ1406MR01, DZ1285MR01, DZ11… System ID: 1009000, 201871MR, DZ1396MR01, DZ1820MR01, DZ1339MR02, DZ1339MR01, DZ1061MR01, DZ1406MR01, DZ1285MR01, DZ1191MR01, 0910272060, 0910274038, 0910274036, BH1038MR01, MRR9112, MRR10326, MRR8777, MRR10248, MRR9308, MRR10649, MRR10657, MRR10586, MRR10646, MRR10703, MRR10694, MRR10648, MRR10676, MRR8247, MRR10417, MRR10842, MRR10620, MRR10145, MRR9922, MRR9979, MRR10393, MRR9829, MRR8339, MRR11105, MRR10416, MRR10514, MRR10812, MRR9091, MRR10742, MRR8318, MRR10418, MRR9927, MRR8632, MRR8679, MRR8213, MRR9379, MRR10692, MRR10259, MRR10205, MRR10330, MRR11034, MRR9826A, MRR10690, MRR9033, MRR10478, MRR10529, MRR8249, MRR9080, MRR8969, MRR10201, MRR8714, MRR10793, MRR10013A, MRR8427, MRR11089, MRR10594, MRR9435, MRR10177, MRR10629, MRR10366, MRR10640, MRR10596, MRR9988, MRR10158, MRR10486, MRR9587, MRR10341, MRR10388, MRR10147, MRR10206, MRR9797, MRR9636A, MRR9450, MRR9947, MRR9271, MRR10227, MRR10062, MRR9000, MR1551SX1, MRR10336, MRR10115, MRR9877, MRR10726, MR1578SX4, MR1462SX1, M

code_info

System ID: 1009000, 201871MR, DZ1396MR01, DZ1820MR01, DZ1339MR02, DZ1339MR01, DZ1061MR01, DZ1406MR01, DZ1285MR01, DZ11…

System ID: 1009000, 201871MR, DZ1396MR01, DZ1820MR01, DZ1339MR02, DZ1339MR01, DZ1061MR01, DZ1406MR01, DZ1285MR01, DZ1191MR01, 0910272060, 0910274038, 0910274036, BH1038MR01, MRR9112, MRR10326, MRR8777, MRR10248, MRR9308, MRR10649, MRR10657, MRR10586, MRR10646, MRR10703, MRR10694, MRR10648, MRR10676, MRR8247, MRR10417, MRR10842, MRR10620, MRR10145, MRR9922, MRR9979, MRR10393, MRR9829, MRR8339, MRR11105, MRR10416, MRR10514, MRR10812, MRR9091, MRR10742, MRR8318, MRR10418, MRR9927, MRR8632, MRR8679, MRR8213, MRR9379, MRR10692, MRR10259, MRR10205, MRR10330, MRR11034, MRR9826A, MRR10690, MRR9033, MRR10478, MRR10529, MRR8249, MRR9080, MRR8969, MRR10201, MRR8714, MRR10793, MRR10013A, MRR8427, MRR11089, MRR10594, MRR9435, MRR10177, MRR10629, MRR10366, MRR10640, MRR10596, MRR9988, MRR10158, MRR10486, MRR9587, MRR10341, MRR10388, MRR10147, MRR10206, MRR9797, MRR9636A, MRR9450, MRR9947, MRR9271, MRR10227, MRR10062, MRR9000, MR1551SX1, MRR10336, MRR10115, MRR9877, MRR10726, MR1578SX4, MR1462SX1, M

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-2478-2024%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.