Philips Medical Systems Nederland B.V. is recalling 78 units of the Azurion 7 M20 Fluoroscopic X-Ray System because the bolts connecting the gearbox to the mounting flange of the C-arm can become loose. This mechanical issue was discovered by the manufacturer and affects systems manufactured in the Netherlands. If the bolts detach, the heavy C-arm component could move unexpectedly or fail during use. Consumers should stop using the system and contact the manufacturer to arrange for a mechanical inspection and repair.
Loose or detached bolts could lead to the unintended movement or detachment of the C-arm component, posing a risk of physical injury to patients or healthcare professionals during medical procedures. While no injuries have been reported, a mechanical failure of this heavy imaging equipment could result in significant harm.
Firm initiated recall via letter.
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 · 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.