Verathon, Inc.: GlideScope Core Monitors Recalled Due to Potential Image Loss or Degradation

Agency Publication Date: June 4, 2024

Summary

Verathon, Inc. is recalling 4,274 GlideScope Core 15-inch monitors because software issues can cause the screen to lose its image or show a degraded picture when connected to other devices. This recall affects the GlideScope Core 15-inch Monitor (Model 0570-0404) and the GlideScope Core 15-inch FHD (Model 0570-0437) running older software versions. These monitors were distributed across most of the United States and several international locations. Consumers should contact the manufacturer or their healthcare provider for further instructions and potential remedies.

Risk

A software defect can cause the monitor to lose its video feed or display a poor-quality image during use with other connected devices. If this occurs during a medical procedure, the loss of visual guidance could lead to delayed treatment or potential patient injury.

What You Should Do

Identify if you have an affected monitor by checking the model and software version: GlideScope Core 15-inch Monitor (Model 0570-0404) with software v1.9 or earlier, or GlideScope Core 15-inch FHD (Model 0570-0437) with software v1.7 or earlier.
Locate the UDI/DI on your device to confirm it matches affected units: 00879123006639 for the 15-inch Monitor or 00879123008596 for the 15-inch FHD.
Contact Verathon, Inc. at their Bothell, Washington headquarters or through your authorized representative to receive information regarding software updates or corrective actions.
Discuss the use of these devices with your healthcare provider or facility's technical department to ensure patient safety while the software issue is addressed.
For further information or to report additional issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer notification and software management

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: GlideScope Core 15-inch Monitor

Model / REF:

0570-0404

UPC Codes:

00879123006639

Lot Numbers:

Software Version: v1.9 and earlier

Product: GlideScope Core 15-inch FHD

Model / REF:

0570-0437

UPC Codes:

00879123008596

Lot Numbers:

Software Version: v1.7 and earlier

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94547

Status: Active

Manufacturer: Verathon, Inc.

Sold By: Authorized medical device distributors

Manufactured In: United States

Units Affected: 2 products (2568 devices; 1706 devices)

Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have an affected monitor by checking the model and software version: GlideScope Core 15-inch Monitor (Model 0570-0404) with software v1.9 or earlier, or GlideScope Core 15-inch FHD (Model 0570-0437) with software v1.7 or earlier.

Locate the UDI/DI on your device to confirm it matches affected units: 00879123006639 for the 15-inch Monitor or 00879123008596 for the 15-inch FHD.

Contact Verathon, Inc. at their Bothell, Washington headquarters or through your authorized representative to receive information regarding software updates or corrective actions.

Discuss the use of these devices with your healthcare provider or facility's technical department to ensure patient safety while the software issue is addressed.

For further information or to report additional issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.