FDA recall Z-2022-2024

Verathon, Inc. · Class II · device

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

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.

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

Key facts

Status
Ongoing
Initiation date
2024-04-29
Report date
2024-06-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bothell, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2022-2024