Reported Aug 14, 2024 · Ongoing
SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1;…
GE Medical Systems, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Medical Systems, LLC · 3200 N Grandview Blvd · Waukesha, WI · 53188-1693
Is this the product you have?
- SIGNA Creator
- with affected software versions
HD16.0_V03 to HD16.4HD23.0_V03HD28.0HD29.1MR30.0MR30.1Nuclear Magnetic Resonance Imaging System
- Lot codes and dates
- System ID
1,817 of 1,817 codes
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
- System ID
- Amount recalled
- 1817 units
This recall covers 26 products
The agency filed one notice per product. You are reading one of them; the other 25 are below.
13 more are in the archive.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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