Z-0916-2020 Class I Terminated
FDA device recall Z-0916-2020 was initiated by King Systems Corp. dba Ambu, Inc. on November 5, 2019 and is designated Class I. 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. The recall status is terminated (terminated March 23, 2021). Affected quantity: 171 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 12, 2020
- Initiation Date
- November 5, 2019
- Termination Date
- March 23, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 171 units
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.
Distribution Pattern
Worldwide distribution. US Nationwide, Australia, Belgium, Bolivia, Canada, Costa Rica, Germany, Hong Kong, India, Italy, Japan, Myanmar, Poland, Spain, and UK.
Code Information
Lot codes: 010614, 010629, 010657, 010668, 010670, 010722; Serial Numbers: LHXXXXXXX10240 LHXXXXXXX10243 LHXXXXXXX10284 LHXXXXXXX10554 LHXXXXXXX10559 LHXXXXXXX10562 LHXXXXXXX10569 LHXXXXXXX10570 LHXXXXXXX10611 LHXXXXXXX10666