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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
Medical Devices/Diagnostic Equipment

NRT X-RAY A/S: Intelli-C X-ray Systems Recalled for Risk of Uncontrolled C-arm Motion

Agency Publication Date: May 7, 2024
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Summary

NRT X-RAY A/S is recalling 35 units of the Intelli-C X-ray system tabletops due to a mechanical and software defect that can cause the heavy C-arm to move uncontrollably. This issue occurs when specific firmware settings are combined with hardware wear, particularly when the machine is operated at maximum speed and steep angles. If the emergency stop is activated during these conditions, the arm may fail to stop correctly, potentially striking the patient or the medical operator. The recall includes both Right side (REF 03400000) and Left side (REF 03400010) suspended tabletops.

Risk

A faulty firmware setting in the motor controller can fail to compensate for wear in the motor and gear assembly, leading to a loss of control over the C-arm's movement. This creates a collision hazard where the heavy medical equipment could hit a patient lying on the table or medical staff standing nearby, causing physical injury.

What You Should Do

  1. Identify if your facility uses the Intelli-C X-ray system by checking for the tabletop model numbers REF 03400000 (Right side suspended) or REF 03400010 (Left side suspended).
  2. Check the serial number on your device's identification plate; affected serial numbers include 627002, 627004, 627007, 639001, 639002, 639003, 639004, 639007, 639010, 647001, 647004, 647005, 648001, 651007, 658002, 658003, 658006, 658010, 666008, 675001, 675004, 682006, 682010, 682011, 696003, 696004, 696006, 696007, 696012, 647009, 651002, 651006, 666009, 682003, and 682023.
  3. If you have an affected unit, contact your facility's medical engineering department or contact the manufacturer, NRT X-RAY A/S, for instructions on receiving the necessary firmware update and equipment inspection.
  4. You may reach the manufacturer directly at Birkegardsvej 16, Hasselager, Denmark, or visit their official website for technical support and recall coordination.
  5. For further information or to report concerns, contact the FDA's medical device recall line at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action

Firmware update and mechanical inspection.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund.

Affected Products

Product: Intelli-C: Right side suspended Tabletop
Model / REF:
REF: 03400000
UPC Codes:
05713464000527
Lot Numbers:
627002
627004
627007
639001
639002
639003
639004
639007
639010
647001
647004
647005
648001
651007
658002
658003
658006
658010
666008
675001
675004
682006
682010
682011
696003
696004
696006
696007
696012
Product: Intelli-C: Left side suspended Tabletop
Model / REF:
REF: 03400010
UPC Codes:
05713464000121
Lot Numbers:
647009
651002
651006
666009
682003
682023

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94363
Status: Active
Manufacturer: NRT X-RAY A/S
Sold By: Direct sales to healthcare facilities; Authorized medical equipment distributors
Manufactured In: Denmark
Units Affected: 35
Distributed To: Ohio, North Carolina, Kentucky, South Carolina, Iowa, Massachusetts, Washington, West Virginia, Louisiana, New York, Pennsylvania, Hawaii, Nevada, Wisconsin, Minnesota, Michigan

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.