King Systems Recalls King Vision Video Laryngoscope Adapter Size ½ Due to a Display of The Reversed Image
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- King Vision Video Laryngoscope Reusable Adapter Size ½, (KVLVA12)
- Lot Numbers: 010614, 010629, 010657, 010668, 010670, 010722
- Serial numbers: LHXXXXXXX10240, LHXXXXXXX10243, LHXXXXXXX10284, LHXXXXXXX10554, LHXXXXXXX10559, LHXXXXXXX10562, LHXXXXXXX10569, LHXXXXXXX10570, LHXXXXXXX10611, LHXXXXXXX10666
- Model Number: KVLVA12
- Manufactured Dates: April 2, 2019 to September 19, 2019
- Distribution Dates: August 2, 2019 to October 25, 2019 in AK, AL, CA, FL, IA, IL, KS, LA, MD, MN, MS, NC, NE, PA, SC, TX, WA, and WI
- Devices Recalled in the U.S.: 107
- Date Initiated by Firm: November 5, 2019
The King Vision Video Laryngoscope Adapter is used to examine a patient’s upper airway and aid in the placement of a tracheal tube. The video adapter connects to the display to show an image. The size ½ video adapter is primarily used in children up to age 10.
KVLVA12 Serial Number Location
Reason for Recall
King Systems is recalling the video adapters because all devices from the affected lots will show a reversed image on the display. Although the image may appear normal, the user’s actions will be reversed on the display for left and right directions. As the defect is not easily detectable, use of the affected video adapter may cause serious adverse health events, including airway trauma and decreased oxygen in your body (hypoxia). The reversed image may also extend the time to place the trachea tube which may lead to brain damage, organ failure and death.
There are no reported injuries or deaths.
Example of Affected Device (KLVA12) Showing a Reversed Image
Who May be Affected
- Health care providers using the King Vision Video Laryngoscope Reusable Adapter Size ½
- Patients having procedures using the King Vision Video Laryngoscope Reusable Adapter Size ½
What to Do
On November 5, 2019 King Systems sent a letter to distributors and customers, stating the product and issue and provided the following instructions:
- Do not use affected devices.
- Identify affected products by reviewing the product packaging for Lot Number or individual devices for Serial Number. The Serial Number is located inside the Adapter.
Consumers with questions may contact King Systems by phone at (410) 768-6464, Monday through Friday between 8:00am and 5:00pm (Eastern Time) or by emailing firstname.lastname@example.org.
- Medical Device Recalls database
- King Systems Issues Recall of King Vision Video Laryngoscope Video Adapter Size 1/2
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.