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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

GE Healthcare, LLC: Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

Agency Publication Date: October 16, 2021
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Affected Products

Product: SIGNA Premier nuclear magnetic resonance imaging system

Software version RX29.1 and RX27.3 (China only)

Product: SIGNA Architect nuclear magnetic resonance imaging system

Software version DV29.1; and DV28.4 (F), DV27.3 (T) (China only)

Product: SIGNA Pioneer nuclear magnetic resonance imaging system

Software version PX29.1; and PX25.4 (T), PX28.3 (China only)

Product: Discovery MR750w 3.0T nuclear magnetic resonance imaging system

Software version DV29.1

Product: Discovery MR750 3.0T nuclear magnetic resonance imaging system

Software version DV29.1

Product: SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system

Software version DV29.1

Product: SIGNA Voyager nuclear magnetic resonance imaging system

Software version VX29.1; and PX26.4 (China only)

Product: SIGNA Artist nuclear magnetic resonance imaging system

Software version DV29.1

Product: Optima MR450w 1.5T nuclear magnetic resonance imaging system

Software version DV29.1

Product: 1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system

Software version HD29.1; and HD16.2 (China only)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88665
Status: Resolved
Manufacturer: GE Healthcare, LLC
Manufactured In: United States
Units Affected: 10 products (11 devices; 2 devices; 5 devices; 13 devices; 5 devices; 6 devices; 15 devices; 18 devices; 13 devices; 3 devices)
Agency Last Updated: November 9, 2021

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.