Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description: Serialized Monitor
Recall
- Recall Number
- Z-2021-2024
- Event Number
- 94547
- Firm
- Verathon, Inc.
- FEI Number
- 3022472
- Product Code
- CCW
- Status
- Open, Classified
- Root Cause
- Software Manufacturing/Software Deployment
- Initiated
- April 29, 2024
- Posted
- June 4, 2024
- Address
- 20001 N Creek Pkwy, Bothell, WA, 98011-8218
Description
Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description: Serialized Monitor
Due to software issues, their is the potential for loss of image or a degradation of the image when using the monitor with other connectable devices.
On April 30, 2024, Verathon issued "Urgent Medical Device Correction" notification via FedEx. Verathon asked consignees to take the following actions: 1. Plug your 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 your GlideScope Core 15 or Core 15 FHD monitor(s) (approximately 5-7 minutes for the upgrade). 3.Verify the software version on the Administrative Settings tab. OR 4.Contact Verathon Customer Care to contact your Territory Manager to perform the upgrade at your facility. 5.Complete the Correction Response Form in this packet and return it to Verathon via email to [email protected]. While your fleet is being updated to the latest software, you can continue using the GlideScope Core 15 or Core 15 FHD Monitor. Always ensure that alternative airway management methods and equipment are readily available, per the American Society of Anesthesiologists (ASA) guidelines.
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2568 devices