Recall Z-1618-2020 ยท EQN Laryngoscope, Nasopharyngoscope
Karl Storz Endoscopy
Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the insp
| Date | Dec 6, 2019 |
| Status | Terminated |
| Reason | The firm has become aware that there is a potential that the glass cover at the distal end of the camera/led lighting on the video laryngoscope could become loose during reprocessing or use. If this occurs during usage, it may result in a delay in procedure and/or require removal from body. |
| Root cause | Labeling Change Control |
| Action | On 12/6/2019 a "Urgent Medical device Correction" letter was sent to affected customers via mail. In addition, to providing information on the recall, the firm asked customers to take the following actions: 1. Please forward this Safety Information to the appropriate departments in your organization. 2. Please train your employees on the new Instructions for Use, especially chapter 5.1. 3. Please complete the attached acknowledgement form and return it to us. 4. If you have any questions about this communication, or needs additional copies of this Instruction for Use, please contact |
| Quantity | 27,165 scopes |
| Distribution | Worldwide distribution - US Nationwide and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.