King Systems Corp. dba Ambu, Inc. recalls King Vision Video Adapter Size 1/2. Laryngoscope used to examine and visualize a patients upper airway and aid in the p…

Recall date

November 5, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0916-2020

FDA classification

Class I

Brand / firm

King Systems Corp. dba Ambu, Inc.

Sold / distributed

Worldwide distribution. US Nationwide, Australia, Belgium, Bolivia, Canada, Costa Rica, Germany, Hong Kong, India, Italy, Japan, Myanmar, Poland, Spain, and UK.

Why it was recalled

Exhibiting a reversed image. Although the image may appear normal, the users actions will be reversed on the display for left and right directions.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

King Vision Video Adapter Size 1/2. Laryngoscope used to examine and visualize a patients upper airway and aid in the placement of a tracheal tube. Model Number: KVLVA12