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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

FUJIFILM Healthcare Americas Corporation: Noblus Ultrasound AC Adapters Recalled Due to Overheating and Smoke Risk

Agency Publication Date: May 22, 2024
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Summary

FUJIFILM Healthcare Americas Corporation is recalling 418 Noblus AC Adapters used with the Noblus Ultrasound Imaging System. The adapters can overheat and potentially emit smoke if the power cable is frequently inserted and removed, causing mechanical stress on the socket. This issue affects units with serial numbers before K17160001 (excluding K17160001). Owners should contact the manufacturer or their healthcare provider for further instructions regarding this equipment.

Risk

Frequent plugging and unplugging of the power cable can cause excessive mechanical stress to the adapter socket, leading it to heat up and, in the worst-case scenario, produce smoke, which poses a fire or inhalation risk.

What You Should Do

  1. Identify your equipment by checking the Noblus Ultrasound Imaging System AC Adapter for model number AHM250PS24 and the unique UDI-DI: (01) 04580292771704.
  2. Check the serial number on your AC adapter; affected units are those with a serial number before K17160001 (excluding K17160001).
  3. Inspect the power cable socket for any signs of heat damage, discoloration, or melting.
  4. Minimize unnecessary insertion and removal of the power cable to reduce mechanical stress on the adapter until it can be inspected or replaced.
  5. Contact FUJIFILM Healthcare Americas Corporation or your medical facility's equipment manager for further instructions and information on potential repairs or replacements.
  6. Call the FDA's consumer hotline at 1-888-463-6332 for additional questions regarding medical device safety.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and guidance

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

Affected Products

Product: Noblus AC Adapter used with the Noblus Ultrasound Imaging System
Model / REF:
AHM250PS24
UPC Codes:
04580292771704
Lot Numbers:
Serial Numbers before K17160001 (Excluding K17160001)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94441
Status: Active
Manufacturer: FUJIFILM Healthcare Americas Corporation
Sold By: FUJIFILM Healthcare Americas Corporation
Manufactured In: United States
Units Affected: 418 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.