| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00342-1 |
| Product Name/Description |
GlideScope Core 15 and GlideScope Core 15 FHD Monitors
Part Numbers: 0570-0404 and 0570-0437
Software Versions: v1.9 and earlier for Core 15 and v1.7 and earlier for Core 15 FHD
ARTG 221998
(Verathon Medical Australia Pty Ltd - Laryngoscope, intubation) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/05/2024 |
| Responsible Entity |
|
| Reason/Issue |
Verathon received complaints from customers in the field, where systems of Spectrum QC Blades in conjunction with 2m QuickConnect (QC) cable, and Core HD/FHD monitors were showing an intermittent problem of screen flickering leading to an eventual loss of image.
This may lead to a delay in the procedure until a replacement or alternative device is obtained, which may cause serious injury.
Until 22 Apr 2024, nine customers have reported events, of which two reported that the event had occurred during set up (before a procedure) and seven reported that the event had occurred during the patient procedure. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers with Software Versions: v1.9 and earlier for Core 15 and v1.7 and earlier for Core 15 FHD will receive a USB containing a software update.
Customers are to:
1. Plug their GlideScope Core 15 or Core 15 FHD into the power supply and connect to a hospital-grade power outlet.
2. Use the enclosed USB drive with the corrective software upgrade and related instructions to upgrade GlideScope Core 15 or Core 15 FHD monitor(s).
3. Verify the software version on the Administrative Settings tab.
OR
4. Contact Verathon Customer Care to perform the upgrade at their facility.
This action has been finalised on 18/7/2024. |
| Contact Information |
CSNotifications@verathon.com - Verathon Customer Care |