LivaNova Deutschland GmbH is recalling 37 of its 3T Heater Cooler Systems (model REF: 16-02-85) because the included Quick Reference Guide contains incorrect maintenance schedule information. This error may lead users to perform critical maintenance at the wrong intervals, potentially affecting the performance and safety of the device during surgical procedures. These systems were distributed nationwide across 11 U.S. states and are identified by specific serial numbers starting with 20T.
Incorrect maintenance instructions can result in the device being improperly serviced, which may lead to equipment malfunction or bacterial growth in the water tanks. Failure to follow the correct disinfection and maintenance protocols can increase the risk of infection or device failure during open-heart surgery.
Labeling correction
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.
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Sources: FDA iRES · Raw API Response
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