GE Medical Systems, LLC recall records

124 reported ongoing

124 records in this archive. Latest source date Jun 5, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System

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 imagin...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging ...
FDA device enforcement

Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

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 imagin...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Re...
FDA device enforcement

Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

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 imagin...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic R...
FDA device enforcement

SIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System

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 imagin...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for SIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System
FDA device enforcement

SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System

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 imagin...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System
FDA device enforcement

SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic Resonance Imaging System - research use only

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 imagin...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic Resonance Imaging Sy...
FDA device enforcement

Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic Resonance Imaging System - research use only

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 imagin...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic Resonance Imaging Syst...
FDA device enforcement

SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Imaging System

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 imagin...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Imaging S...
FDA device enforcement

SIGNA MAGNUS, with affected software versions: MR29.1, RX29.1; Nuclear Magnetic Resonance Imaging System - research use only

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 imagin...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for SIGNA MAGNUS, with affected software versions: MR29.1, RX29.1; Nuclear Magnetic Resonance Imaging...
FDA device enforcement

B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,

GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea level.

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,
FDA device enforcement

Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cepha...

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT,...

Official source for Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; ...
FDA device enforcement

Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cepha...

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT,...

Official source for Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; ...
FDA device enforcement

Vivid S5 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neon...

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT,...

Official source for Vivid S5 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/O...
FDA device enforcement

Vivid S6 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neon...

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT,...

Official source for Vivid S6 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/O...
FDA device enforcement

Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetri...

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT,...

Official source for Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K0921...
FDA device enforcement

Vivid q ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephal...

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT,...

Official source for Vivid q ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; P...

Reasons in these listed records

  • 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 select...
  • GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea level.
  • Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

These examples come from this result page and are not a ranking of every recall reason.

Checking GE Medical Systems, LLC

Is there a recall on ge medical systems, llc right now?

This archive contains 124 records, including 124 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

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What if the search finds no matching record?

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Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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