Recall Z-0916-2020 ยท CCW Laryngoscope, Rigid
King Systems Corp. dba Ambu, Inc.
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
| Date | Feb 4, 2020 (initiated Nov 5, 2019) |
| Status | Terminated |
| Reason | 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 | 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 th |
| Quantity | 171 units |
| Distribution | Worldwide distribution. US Nationwide, Australia, Belgium, Bolivia, Canada, Costa Rica, Germany, Hong Kong, India, Italy, Japan, Myanmar, Poland, Spain, and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.