NA SIGNA Creator (UDI 00840682113786)Recalls & reported problems

Ge Healthcare(Tianjin) Company Limited · SIGNA Creator System Medical Device · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840682113786), received between Feb 25, 2025 and Feb 25, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

13 other recalls cover devices cleared under the same FDA submission (K143251); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Jan 31, 2025Open, Classified
For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.
Z-1239-2025 · Root cause: Software design · FDA record ↗

Most reported problems

Device problems

Insufficient Device Problem Information1
Use of Device Problem1

Patient problems

Laceration(s)1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryFeb 25, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information
DURING SERVICING OF A GEHC MR SYSTEM, A SERVICE CONTRACTOR BROUGHT A FERROUS CRIMPING TOOL INTO THE MAGNET ROOM WHEN IT WAS PULLED FROM THEIR HAND BY THE MAGNET. IT IS REPORTED THE SERVICE CONTRACTOR SUSTAINED A DISLOCATED FINGER AND LACERATION TO THE RIGHT PALM THAT WAS SUTURED.
Patient problems: Laceration(s)
MAUDE report 21458705 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K143251. One submission often covers many models, so check the product and lot details in each record.

Z-1242-2025 · Jan 31, 2025 · Open, Classified
SIGNA MR355, SIGNA MR360, NMRI system
Z-2475-2024 · Jun 14, 2024 · Open, Classified
SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
Z-2473-2024 · Jun 14, 2024 · Open, Classified
SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Z-2476-2024 · Jun 14, 2024 · Open, Classified
SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
Z-2472-2024 · Jun 14, 2024 · Open, Classified
SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Z-2470-2024 · Jun 14, 2024 · Open, Classified
SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Z-0597-2022 · Dec 23, 2021 · Open, Classified
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR355 and SIGNA MR360 System, nuclear magnetic resonance imaging system.
Z-0596-2022 · Dec 23, 2021 · Open, Classified
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Creator and SIGNA Explorer System, nuclear magnetic resonance imaging system.
Z-0137-2022 · Aug 26, 2021 · Terminated
SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system
Z-2058-2021 · Jun 4, 2021 · Open, Classified
SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System
Z-2059-2021 · Jun 4, 2021 · Open, Classified
SIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging System
Z-3026-2017 · May 11, 2017 · Terminated
SIGNA Creator, SIGNA ExplorerProduct Usage: 1.5T SIGNA Creator and 1.5T SIGNA Explorer is a whole body magnetic resonance scanner designed to support high resolution, high signal-t
Z-2731-2016 · Aug 31, 2016 · Terminated
GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.

Device details

UDI-DI	`00840682113786`
Brand	NA
Model	SIGNA Creator
Company	Ge Healthcare(Tianjin) Company Limited
Product code	LNH · System, nuclear magnetic resonance imaging
Class	Class 2
FDA submission	K143251
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jan 30, 2026

Device type (GMDN): Full-body MRI system, superconducting magnet

A diagnostic general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body (full-body imaging). This system includes a superconducting magnet assembly and can be fixed-location, mobile, or transportable. Some systems can perform MR spectroscopy or various real-time imaging procedures for MRI guided interventional, therapeutic, or surgical applications. The system is available in a variety of system gantry configurations including closed bore, open bore, and open-sided or other kinds of patient accessible designs.

Other System, nuclear magnetic resonance imaging devices

Ingenia Ingenia Elition X
Philips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging
14 recalls12 reports
Ingenia Elition S
Philips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging
13 recalls2 reports
NA Discovery MR750w 3.0T
GE Medical Systems, L.L.C. · System, nuclear magnetic resonance imaging
13 recalls0 reports
Ingenia Ingenia Ambition X
Philips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging
12 recalls12 reports
Ingenia Ingenia 3.0T CX
Philips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging
11 recalls59 reports
Ingenia Smartpath to dStream for 3.0T
Philips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging
11 recalls44 reports
Ingenia Ingenia Elition X
Philips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging
11 recalls5 reports
MR 7000 Series MR 7700
Philips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging
11 recalls4 reports

All System, nuclear magnetic resonance imaging devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page