SEDECAL SA has issued a voluntary recall for 2,185 units of several mobile diagnostic X-ray systems, including AeroDR X30 and MobileDiagnost wDR 2.2 models. These devices are not water-resistant, and improper cleaning that allows liquid to enter the equipment housing can cause hardware damage or electrical issues. While no injuries have been reported, the firm is reminding clinical users to follow cleaning instructions exactly as outlined in the device manual to prevent malfunction. Users should contact their distributor or Sedecal to ensure they have the most up-to-date maintenance guidance.
If cleaning liquids or other fluids enter the device housing, it can cause internal damage that results in equipment failure or electrical hazards. This may lead to delays in patient diagnosis if the system becomes unavailable during clinical use.
Recall #: Z-0242-2026
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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.
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.