Brand Name: GlideScope Core 15-inch FHD Model/Catalog Number: 0570-0437 Software Version: Core 15 FHD v1.7 and earlier
Summary
The FDA issued a Class II for Brand Name: GlideScope Core 15-inch FHD Model/Catalog Number: 0570-0437 Softwa by Verathon, Inc.. 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..
Details
Source
Device Recall
External ID
Z-2022-2024
Action Date
2024-06-12
Status
Ongoing
Category
device
Product 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
Lot/Code Info: Software versions: v1.7 and earlier/UDI/DI: 00879123008596
Quantity Affected: 1706 devices
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
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-29
Company
Bothell, WA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 212 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Verathon, Inc. has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Verathon, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Verathon, Inc. have FDA actions?
Verathon, Inc. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2022-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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