Z-2021-2024Class II

Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description: Serialized...

Name: Z-2021-2024 Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description: Serialized...
Creator: Verathon, Inc.
Published: 2024-04-29
License: https://open.fda.gov/license/

Verathon Inc. / initiated 2024-04-29 / Open, Classified / root cause: software

FDA source

Verathon, Inc. began a recall of Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description: Serialized Monitor on 2024-04-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2021-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-29
Posted: 2024-06-04
Recalling firm: Verathon Inc.
Product: Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description: Serialized Monitor
Product code: CCW Laryngoscope, Rigid
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.
Root cause tag: software
FDA 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 [email protected]. 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 in commerce: 2568 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
Product codes and lots: Software Version: v1.9 and earlier/ UDI: UDI/DI: 00879123006639

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2021-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2021-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-12	2024-06-04
Z-2022-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-12	2024-06-04

Product code CCW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)