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Lower risk Medical device recall · FDA · Published April 24, 2026

GE Healthcare - Medical Imaging Systems

GE Healthcare offers a wide range of medical imaging systems including CT, MRI, X-ray, and ultrasound equipment for clinical and research applications.

🇺🇸 FDA recall #Z-2279-2026Medical deviceGE ›
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Recalling firmGE Medical Systems Information Technologies Inc9900 W Innovation Dr · Milwaukee, WI 53226-4856
✎ GovInfoNow plain-language explainer

GE Healthcare provides advanced medical imaging solutions such as CT, MRI, X-ray, and ultrasound systems designed for clinical and research environments. Their products are used in hospitals, clinics, and laboratories worldwide. Read more at govinfonow.com/recall/49384-ge-healthcare-medical-imaging-systems.

Source Summary by GovInfoNow · govinfonow.com/recall/49384-ge-healthcare-medical-imaging-systems · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2279-2026

Cite this page

“GE Healthcare - Medical Imaging Systems.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49384-ge-healthcare-medical-imaging-systems. Based on FDA recall #Z-2279-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2279-2026%22&limit=1).

The FDA has issued a voluntary recall initiated by GE Medical Systems Information Technologies Inc for Class II devices distributed worldwide.

How to tell if you have it

  • GE Medical Systems Information Technologies Inc
  • FDA

The hazard

The provided fact pack does not specify a hazard for this specific recall; however, recent related recalls by GE Medical Systems have involved delays in patient monitoring and software vulnerabilities leading to loss of monitoring.

Context

This recall involves 1835 units with worldwide distribution, including the US, Algeria, Australia, Bangladesh, Cambodia, Canada, Croatia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Ireland, Italy, Japan, South Korea, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Philippines, Poland, Qatar, Romania, Saudi Arabia, Senegal, Singapore, South Africa, Spain, Sri Lanka, Sweden, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, and the United Kingdom. GE Medical Systems Information Technologies Inc has 11 other recalls on record since 2017-07-13.

How to tell if you have this one

Ensure proper calibration, regular maintenance, and adherence to safety protocols when using GE Healthcare imaging systems.

  • Brand
    GE
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. 1

    Verify the system's calibration and maintenance records.

  2. 2

    Ensure that the system is being used by trained personnel.

  3. 3

    Follow all safety guidelines provided by the manufacturer.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Bangladesh, Cambodia, Canada, Croatia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Ireland, Italy, Japan, South Korea, Lebanon,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 47 days after the firm started it.

1. Firm started the recall: Apr 24, 202612. FDA classified it Class II: Jun 1, 202623. Published in FDA’s Enforcement Report: Jun 10, 202632026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

How often should GE Healthcare imaging systems be maintained?

Regular maintenance is recommended by the manufacturer. Typically, imaging systems require annual or semi-annual maintenance checks depending on usage and the specific system.

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Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2279-2026 (April 24, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2279-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA