Zyno Medical LLC is recalling 574 units of the Zyno Medical Z-800WF Large Volume Infusion Pump because of a software glitch in version 5.2.05. When the "patient query" feature is used, the device's alarm volume can automatically drop from a loud setting to a very low one without warning. If medical staff cannot hear the alarm, they may not notice if the pump stops delivering critical medications or fluids, which could lead to treatment delays. In severe cases, this failure can cause serious harm, including organ failure or death. Consumers and healthcare facilities should identify these specific pumps and contact the manufacturer for guidance on software updates or corrections.
The software defect causes critical safety alarms to revert to a low volume setting that may be inaudible to healthcare providers. If a malfunction occurs and the alarm is not heard, the patient may suffer from a lack of necessary intravenous therapy, posing a significant risk of life-threatening complications.
Software correction and manufacturer instructions
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.
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Sources: FDA iRES · Raw API Response
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