WASHINGTON, D.C. — Medical device manufacturer King Systems announced a recall of 171 of its King Vision video laryngoscope adaptors because of an issue that results in a flipped image. According to the U.S. Food and Drug Administration, King Systems said that the adapter size it will recall is ½. All other King Systems video adapters are believed to be acceptable to use. The U.S. Food and Drug Administration (FDA) will work in conjunction with King Systems to ensure that all 171 video systems are returned to King Systems as expeditiously as possible. To this point, King Systems has not learned of any reports of injuries or complications caused by the reversed images.
The FDA said that the product must be returned to King Systems and no longer used because of the threat posed to the patient when doctors use a reversed image on a laryngoscope to intubate a patient. The reversed image could also delay intubation and potentially cause an injury. The FDA also said that although a reversed image might show the surfaces as normal, reversing left and right can cause an injury or complicate intubation. King Systems reported that the vertical imaging capabilities of the adapters had not been affected by the issue.
King Systems indicated that medical staff must stop using the company’s adapters made from April 2, 2019, and September 19, 2019. King Systems distributed the recalled products from August 2, 2019, to October 25, 2019. King Systems reported that it shipped 107 recalled adapters in the United States and 64 internationally among fifteen countries.
King Systems asked physicians to report any adverse medical outcomes to the company. Currently, there have not even any reports made to King Systems or the FDA concerning adverse events. The FDA said that King Systems announced the recall voluntarily. Furthermore, the FDA indicated that numerous users of the product reported the problem to King Systems, who subsequently took action.
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