King Vision Video Adapter Size 1/2. Laryngoscope used to examine and visualize a patients upper ...
FDA Device Recall #Z-0916-2020 — Class I — November 5, 2019
Recall Summary
| Recall Number | Z-0916-2020 |
| Classification | Class I — Serious risk |
| Date Initiated | November 5, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | King Systems Corp. dba Ambu, Inc. |
| Location | Noblesville, IN |
| Product Type | Devices |
| 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.
Lot / Code Information
Lot codes: 010614, 010629, 010657, 010668, 010670, 010722; Serial Numbers: LHXXXXXXX10240 LHXXXXXXX10243 LHXXXXXXX10284 LHXXXXXXX10554 LHXXXXXXX10559 LHXXXXXXX10562 LHXXXXXXX10569 LHXXXXXXX10570 LHXXXXXXX10611 LHXXXXXXX10666
Other Recalls from King Systems Corp. dba Ambu, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0269-2025 | Class II | AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STER... | Sep 26, 2024 |
| Z-0270-2025 | Class II | KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserte... | Sep 26, 2024 |
| Z-0276-2025 | Class II | KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE ... | Sep 26, 2024 |
| Z-0274-2025 | Class II | KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KI... | Sep 26, 2024 |
| Z-0275-2025 | Class II | KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KI... | Sep 26, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.