FDA Device recall Z-2302-2025
GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System
- FDA Device
- Class II
- ongoing
- Published 2025-08-20
On 2025-08-20 the FDA classified a Class II recall of GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System by Ge Medical Systems, citing GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Disco….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2302-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-20 |
| Published | 2025-08-20 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ge Medical Systems |
| Distribution | n/a |
Product
GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System
Reason
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
Identifiers
| code_info | 00195278023643, 00195278117021, 00195278126443, 00195278210036, 00195278229519, 00840682115971, 00840682118118, 0084068…00195278023643, 00195278117021, 00195278126443, 00195278210036, 00195278229519, 00840682115971, 00840682118118, 00840682118132, 00840682123129, 00840682123457, 00840682123457, 00840682146104, Not applicable, Not available; All System ID numbers that GE HealthCare performed planned maintenance on since March 1, 2023 |
|---|
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-2302-2025%22
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