Maquet Critical Care AB is recalling 8,691 Servo-u, Servo-n, and Servo-u MR Ventilator Systems because they may provide inaccurate measurements of the patient circuit's compliance. This issue occurs when an incorrect pre-use leakage test is combined with the use of certain active humidifiers. The recall affects 8,691 units across three models and includes all software versions.
Inaccurate compliance measurements can cause the ventilator to deliver incorrect breathing support to the patient. This defect could result in the patient receiving the wrong volume of air, potentially leading to respiratory distress or lung injury.
874 units affected.
7,688 units affected.
129 units affected.
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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