Approximately 61 units of the BD Pyxis CII Safe ES and Enterprise Server products are being recalled because a software defect can silently overwrite critical security settings. When using the 'global edit' feature to update multiple settings at once, the system automatically changes several important security controls—such as requiring a witness for medication destruction—to 'NO' without warning the user. This issue affects software versions 1.7.3 and 1.7.4, which were distributed across several states including California, Michigan, and New York.
The software defect disables security protocols designed to track controlled substances, which could result in the unauthorized diversion of high-risk medications from automated dispensing cabinets without detection. This failure of the inventory control system poses a medium risk to hospital security and patient safety by allowing controlled substances to be removed or destroyed without the required oversight.
Manufacturer initiated contact via letter to address software settings overwriting.
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.