Recall Z-2021-2024
Verathon, Inc. · initiated April 29, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description: Serialized Monitor
Codes / lots: Software Version: v1.9 and earlier/ UDI: UDI/DI: 00879123006639
Reason for recall
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.
FDA-determined cause: Software Manufacturing/Software Deployment
Action taken
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 CSNotifications@verathon.com. 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.
Details
- Recall number
- Z-2021-2024
- Initiated
- April 29, 2024
- Posted by FDA
- June 4, 2024
- Product code
- CCW – Laryngoscope, Rigid
- Quantity
- 2568 devices
- Distribution
- US: AK AL AR AZ CA CO CT DC FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK ON OR PA QLD RI SC SD TN TX UT VA VIC WA WI WV WY OUS: Hong Kong, Indonesia, Saudi Arabia
- Recalling firm
- Verathon, Inc., Bothell, WA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2022-2024 Class II | Brand Name: GlideScope Core 15-inch FHD Model/Catalog Number: 0570-0437 Software…Due to software issues, their is the potential for loss of image or a degradation of the image when using… | 04/29/2024Open, Classified |