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U.S. Department of Health and Human Services

Class 1 Device Recall King Vision Video Adapter Size 1/2

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  Class 1 Device Recall King Vision Video Adapter Size 1/2 see related information
Date Initiated by Firm November 05, 2019
Date Posted February 04, 2020
Recall Status1 Terminated 3 on March 23, 2021
Recall Number Z-0916-2020
Recall Event ID 84415
Product Classification Laryngoscope, rigid - Product Code CCW
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
Code Information Lot codes: 010614, 010629, 010657, 010668, 010670, 010722;   Serial Numbers: LHXXXXXXX10240 LHXXXXXXX10243 LHXXXXXXX10284 LHXXXXXXX10554 LHXXXXXXX10559 LHXXXXXXX10562 LHXXXXXXX10569 LHXXXXXXX10570 LHXXXXXXX10611 LHXXXXXXX10666
Recalling Firm/
Manufacturer		 King Systems Corp. dba Ambu, Inc.
15011 Herriman Blvd
Noblesville IN 46060-4253
For Additional Information Contact SAME
317-776-6823
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action King Systems issued notification letter -Urgent Medical Device Recall to Domestic consignees notified via E-mail on 11/5/19 with attached letters and forms. Foreign consignees were notified according to local regulation. On January 24, 2020, King Systems issued a Press Release dated 1/20/2020. Customers are advised to take the following action: 1) Review your current inventory and place any affected products in quarantine immediately. 2) The affected products should NOT be used. 3) Please note any affected quantity of product(s) on the attached form and return it within 30 days from the date of this letter by email to Shelby Mitchell (shmi@ambu.com). King Systems asks that you please return all affected product(s). Please contact Shelby Mitchell at +l (410) 768-6464 or email shmi@ambu.com to arrange Return Authorization and credit/replacement
Quantity in Commerce 171 units
Distribution Worldwide distribution. US Nationwide, Australia, Belgium, Bolivia, Canada, Costa Rica, Germany, Hong Kong, India, Italy, Japan, Myanmar, Poland, Spain, and UK.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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