FDA-Device2024-08-14Class II
SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Hazard
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.
Sold states
Worldwide distribution.
Affected count
1227 units
Manufactured in
3200 N Grandview Blvd, Waukesha, WI, United States
Products
SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2469-2024More GE Medical Systems, LLC recalls
- FDA-Device2026-06-17GE HealthCare Allia IGS 3 Pulse angiographic X-ray system recalled for electrical shock risk to service personnel
- FDA-Device2026-06-17GE Allia IGS Pulse X-ray system recalled for electrical shock risk to service personnel
- FDA-Device2026-06-17GE HealthCare Allia Moveo X-ray system recalled for electrical shock risk to service personnel
- FDA-Device2026-06-17GE Allia IGS 5 Pulse angiographic X-ray system recalled for electrical shock risk to service personnel
- FDA-Device2026-06-17GE Allia IGS 7 Pulse X-ray system recalled for electrical shock risk to service personnel
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