Agency classClass IOur severity:Severe FDA (Devices)·Z-0916-2020·Announced 2020-02-12

King Vision Video Adapter Recalled for Reversed Image Display

King Systems Corp. is recalling King Vision Video Adapters because the display shows a reversed image, causing left and right actions to be inverted.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Exhibiting a reversed image. Although the image may appear normal, the users actions will be reversed on the display for left and right directions."

Plain-English summary

King Systems Corp. dba Ambu, Inc. is recalling 171 units of the King Vision Video Adapter Size 1/2, Model Number KVLVA12. The device is a laryngoscope used to examine and visualize a patient's upper airway and aid in the placement of a tracheal tube.

The recall was initiated because the device exhibits a reversed image on the display. While the image may appear normal, the user's actions for left and right directions are reversed on the screen.

The affected units were distributed worldwide, including in the United States, Australia, Belgium, Bolivia, Canada, Costa Rica, Germany, Hong Kong, India, Italy, Japan, Myanmar, Poland, Spain, and the UK. Specific lot codes and serial numbers are listed in the recall documentation. Users should stop using the affected devices and contact the manufacturer for instructions.

The recalled product

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
Manufacturer: King Systems Corp. dba Ambu, Inc.
Category: Medical Device — Laryngoscope
Hazard: display-error
Affected units: 171

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

Lot codes: 010614
010629
010657
010668
010670
010722

Distribution

Distributed nationwide across the United States.

Same manufacturer · King Systems Corp. dba Ambu, Inc.

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