Skip to content

GlideScope recallZ-2021-2024 · Verathon, Inc. · initiated Apr 29, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Verathon, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Software Manufacturing/Software Deployment

What the company is doing

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.

Recall details

Recall number
Z-2021-2024
Status
Open, Classified
Initiated by the company
Apr 29, 2024
Posted by the FDA
Jun 4, 2024
Recalling firm
Verathon, Inc.
Quantity
2568 devices
Product code
CCW
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 description

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

Code information (models, lots, serial numbers)

Software Version: v1.9 and earlier/ UDI: UDI/DI: 00879123006639

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 94547).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page