Z-0916-2020Class I

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

Name: Z-0916-2020 King Vision Video Adapter Size 1/2. Laryngoscope used to examine and visualize a patients upper airway and...
Creator: King Systems Corp. dba Ambu, Inc.
Published: 2019-11-05
License: https://open.fda.gov/license/

King Systems Corporation. / initiated 2019-11-05 / Terminated / root cause: manufacturing process

FDA source

King Systems Corp. dba Ambu, Inc. began a recall of 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... on 2019-11-05. FDA classified it as Class I and gives the reason as "Exhibiting a reversed image. Although the image may appear normal, the users actions will be reversed on the display for left and right directions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0916-2020
Classification: Class I
Status: Terminated
Initiated: 2019-11-05
Posted: 2020-02-04
Terminated: 2021-03-23
Recalling firm: King Systems Corporation.
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
Product code: CCW Laryngoscope, Rigid
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.
Root cause tag: manufacturing process
FDA root cause: 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 ([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
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.
Product codes and lots: Lot codes: 010614, 010629, 010657, 010668, 010670, 010722; Serial Numbers: LHXXXXXXX10240 LHXXXXXXX10243 LHXXXXXXX10284 LHXXXXXXX10554 LHXXXXXXX10559 LHXXXXXXX10562 LHXXXXXXX10569 LHXXXXXXX10570 LHXXXXXXX10611 LHXXXXXXX10666

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0916-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0916-2020	Class I	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-04

Product code CCW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)