King Systems announced that it initiated a voluntary recall of 171 units of its King Vision video laryngoscope adapter size 1/2 because of an issue where the device exhibits a reversed image.
Any product that displays a reversed image could potentially cause difficulty navigating during intubation and/or a delay in intubation, according to an FDA statement. Even if the image appears normal, actions may be reversed on the display for left and right directions.
However, up and down directions on the device are not affected. As of last week, King Systems said it has not received any reports of adverse events or patient injuries resulting from the adapter issue.
King Systems said the affected products should not be used and must be returned to the company. Affected adapters were manufactured from April 2, 2019, to Sept. 19, 2019, and distributed between Aug. 2, 2019, and Oct. 25, 2019.
The company said it has notified anyone impacted by the recall and is arranging for the return and credit or replacement for all recalled products. In total, 107 adapters were shipped in the U.S. and 64 were shipped internationally, with 15 countries affected.