FDAClass IIJune 12, 2024

Brand Name: GlideScope Core 15-inch Monitor recall: Impurity Out of Spec

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

Why was Brand Name: GlideScope Core 15-inch Monitor 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description: Serialized Monitor
Recalling firm
Verathon, Inc.
Quantity
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
Recall date
June 12, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls