King Vision Video Adapter Size 1/2. Laryngoscope used to examine and visualize a patients upper airway and aid in the pl

FDA device recall Z-0916-2020 · posted 2020-02-04 · Terminated

Recall details

Recalling firm

King Systems Corp. dba Ambu, Inc.

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.

Action taken

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

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

CCW

Quantity affected

171 units

Distribution

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

Date initiated

2019-11-05

Date posted

2020-02-04

Date terminated

2021-03-23

Location

Noblesville, IN