Recall Z-0916-2020— King Systems Corp. dba Ambu, Inc.
Class I · Terminated
Class I FDA medical device recall by King Systems Corp. dba Ambu, Inc., initiated 2019-11-05, terminated 2021-03-23. FDA's recall record names no specific 510(k) clearance for this event. 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: Exhibiting a reversed image. Although the image may appear normal, the users actions will be reversed on the display for left and right directions..
- Recalling firm
- King Systems Corp. dba Ambu, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2019-11-05
- Terminated
- 2021-03-23
- Firm location
- Noblesville, IN, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.