AURIS HEALTH INC is recalling 180 units of the Monarch Platform used for endoscopy, bronchoscopy, and urology procedures due to a defect in the power cord strain relief on carts and towers. This defect can cause an electrical short circuit, leading to sudden system shutdowns during medical procedures which may result in prolonged surgery or the need to switch to alternative surgical methods. Identifying details include specific REF and model numbers for the Monarch Platform systems distributed across the United States and Canada.
The power cord defect can expose internal wires; if operating room staff touch these exposed wires or conductive fluids in contact with them, they may suffer an electrical shock. Additionally, a sudden system shutdown during a procedure poses a risk of patient injury due to procedure delays or unplanned case conversions.
Manufacturer 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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