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Terminated

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

FDA Recall Z-0916-2020 · Posted 2020-02-04

Recalling FirmKing Systems Corp. dba Ambu, Inc.
Recall StatusTerminated
Product CodeCCW
Date Initiated2019-11-05
Date Terminated2021-03-23
Product Quantity171 units

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.

Firm 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 ([email protected]). King Systems asks that you please return all affected product(s). Please contact Shelby Mitchell at +l (410) 768-6464 or email [email protected] to arrange Return Authorization and credit/replacement

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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