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U.S. Department of Health and Human Services

Class 2 Device Recall GlideScope Core 15inch FDH Monitor

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 Class 2 Device Recall GlideScope Core 15inch FDH Monitorsee related information
Date Initiated by FirmApril 29, 2024
Date PostedJune 04, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2022-2024
Recall Event ID 94547
Product Classification Laryngoscope, rigid - Product Code CCW
ProductBrand Name: GlideScope Core 15-inch FHD Model/Catalog Number: 0570-0437 Software Version: Core 15 FHD v1.7 and earlier Product Description: Serialized Monitor
Code Information Software versions: v1.7 and earlier/UDI/DI: 00879123008596
FEI Number 3022472
Recalling Firm/
Manufacturer		 Verathon, Inc.
20001 N Creek Pkwy
Bothell WA 98011-8218
For Additional Information ContactCorey Kasbohm
425-6295760
Manufacturer 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.
FDA Determined
Cause 2		Software Manufacturing/Software Deployment
ActionOn 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 CSNotifications@verathon.com. 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 Commerce1706 devices
DistributionUS: 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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