GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or ...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1960-2012.
GE Healthcare has become aware of a potential safety issue due to incorrect alignment of fused CT and PET images associated with the CT/PET fusion capabilities of your Volume Viewer and CT/PET Fusion application. Volume Viewer allows two studies (one PET and one CT) that are registered in the same spatial domain to be viewed simultaneously in fused mode. The two images should be aligned to th
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1960-2012.
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-1960-2012.
GE Healthcare, LLC
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Ge Healthcare, Llc Recall FAQ
Ge Healthcare, Llc is the subject of a medical devices safety report: GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or .... The notice was published on May 24, 2012 by the U.S. Food and Drug Administration (FDA). Approximately 70 units are potentially affected.