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Recall Observatory FDA recall evidence

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

Z-0916-2020

November 05, 2019

Class I

Product summary

Firm
King Systems Corp. dba Ambu, Inc.
Event
Event 84415
Status
Terminated
Classification
Class I
Quantity
171 units
Official record key
device-enforcement:Z-0916-2020

Official wording

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.

Code information: Lot codes: 010614, 010629, 010657, 010668, 010670, 010722; Serial Numbers: LHXXXXXXX10240 LHXXXXXXX10243 LHXXXXXXX10284 LHXXXXXXX10554 LHXXXXXXX10559 LHXXXXXXX10562 LHXXXXXXX10569 LHXXXXXXX10570 LHXXXXXXX10611 LHXXXXXXX10666

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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