FDA recall Z-0916-2020

King Systems Corp. dba Ambu, Inc. · Class I · device

Product

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

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2019-11-05
Report date
2020-02-12
Termination date
2021-03-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Noblesville, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0916-2020