GE Medical Systems, LLC 2024-08-14 Health serious FDA
Health · FDA · Recall #FDA-Z-2473-2024
SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1;… Recall
Issued August 14, 2024 · GE Medical Systems, LLC
In August 2024, GE Medical Systems, LLC recalled the SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1;…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1;… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact GE Medical Systems, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- GE Medical Systems, LLC
- Category
- Health
- Recall date
- August 14, 2024
- Units affected
- Not reported
- Sold at
- Worldwide distribution.
- Recall number
- FDA-Z-2473-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- GE Medical Systems, LLC has 12 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.