GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names: 1.5T CXK4 LCC MAGNET,1.5T EXCITE, 1.5T EXCI...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0110-2019.
The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data mismatch.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0110-2019.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0110-2019.
GE Medical Systems, LLC
About the U.S. Food and Drug Administration
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Visit FDA.gov →📣 Report an adverse event to the FDA (MedWatch)
If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Ge Medical Systems, Llc Recall FAQ
Ge Medical Systems, Llc is the subject of a medical devices safety report: GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names: 1.5T CXK4 LCC MAGNET,1.5T EXCITE, 1.5T EXCI.... The notice was published on June 7, 2018 by the U.S. Food and Drug Administration (FDA). Approximately 5,200 units are potentially affected.