FDA Enforcement
Class II
Ongoing
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: Z-2022-2024
·
Reported June 12, 2024
Enforcement
- Recall Number
- Z-2022-2024
- Event ID
- 94547
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Verathon, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 12, 2024
- Initiation Date
- April 29, 2024
- Classification Date
- June 4, 2024
- Address
- 20001 N Creek Pkwy, N/A, Bothell, WA, 98011-8218, United States
Description
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
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.
Code Info
Software versions: v1.7 and earlier/UDI/DI: 00879123008596
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
Quantity
1706 devices