FDA Medical Device Recalls (openFDA)
Verathon, Inc.: Brand Name: GlideScope Core 15-inch FHD Model/Catalog Number: 0570-0437 Software Version: Core 15 FHD v1.7 and earlier Product Description: Serialized Monitor
- Recall number
- Z-2022-2024
- Recalling firm
- Verathon, Inc.
- Product
- Brand Name: GlideScope Core 15-inch FHD Model/Catalog Number: 0570-0437 Software Version: Core 15 FHD v1.7 and earlier Product Description: Serialized Monitor
- Status
- Open, Classified
- Initiated
- 2024-04-29
- Posted
- 2024-06-04
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Software Manufacturing/Software Deployment
- Action
- 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.
- Quantity
- 1706 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
- Lot, serial or model codes
- Software versions: v1.7 and earlier/UDI/DI: 00879123008596
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CCW
- Firm FEI
- 3022472
- Firm city
- Bothell
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28