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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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High RiskFDA Device
Medical Devices/Diagnostic Equipment

GE Nuclear Medicine Systems Recalled for Detector Fall Risk

Agency Publication Date: January 9, 2026
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Summary

GE HealthCare has recalled 60 Nuclear Medicine imaging systems, including the SMV DSX New Line, SMV DSI, SMV BodyTrack, and MAXXUS models. These older systems, which are past their guaranteed service period, may have been transported or moved without proper support for their heavy detectors, potentially damaging the mounting parts. This defect could cause a detector to fall, which can result in life-threatening bodily injury. No falls or injuries have been reported to date.

Risk

The heavy imaging detector can fall if the mounting mechanism has been stressed or compromised, which could strike a patient or medical staff member and cause life-threatening injury.

What You Should Do

  1. This recall involves discontinued GE Nuclear Medicine tomography systems, specifically the SMV DSX New Line, SMV DSI, SMV BodyTrack, and MAXXUS models, which are past their End of Guaranteed Service period.
  2. Identify the affected systems by checking the model name on the equipment or service records. All serial numbers for these models currently in distribution are included in this recall. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information or to report any incidents.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: SMV DSX New Line, System, Tomography, Computed, Emission
Model / REF:
SMV DSX New Line
Serial Numbers:
All serial numbers in distribution

Recall #: Z-1044-2026; Quantity: 7 units

Product: SMV DSI, System, Tomography, Computed, Emission
Model / REF:
SMV DSI
Serial Numbers:
All serial numbers in distribution

Recall #: Z-1045-2026; Quantity: 3 units

Product: SMV BodyTrack, System, Tomography, Computed, Emission
Model / REF:
SMV BodyTrack
Serial Numbers:
All serial numbers in distribution

Recall #: Z-1046-2026; Quantity: 12 units

Product: MAXXUS, System, Tomography, Computed, Emission
Model / REF:
MAXXUS
Serial Numbers:
All serial numbers in distribution

Recall #: Z-1047-2026; Quantity: 38 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98133
Status: Active
Manufacturer: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Sold By: Authorized Distributors; GE HealthCare
Manufactured In: Israel
Units Affected: 4 products (7 units; 3 units; 12 units; 38 units)
Distributed To: Nationwide

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.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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 ยท 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.