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U.S. Department of Health and Human Services

Class 1 Device Recall GlideScope Core OneTouch Smart Cable

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  Class 1 Device Recall GlideScope Core OneTouch Smart Cable see related information
Date Initiated by Firm June 05, 2020
Create Date July 10, 2020
Recall Status1 Open3, Classified
Recall Number Z-2476-2020
Recall Event ID 85705
Product Classification Laryngoscope, rigid - Product Code CCW
Product GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope Video Laryngoscope System

Per PLRA: The Core OneTouch Cables (Reusable Device) is ancillary equipment used with the Core 10 and Core 15 monitors. The monitor and workstation are intended to work with video endoscopes, in conjunction with ancillary equipment, for endoscopic procedures.
Code Information All serial numbers
Recalling Firm/
Manufacturer
Verathon, Inc.
20001 N Creek Pkwy
Bothell WA 98011-8218
For Additional Information Contact
425-892-0230
Manufacturer Reason
for Recall
When video laryngoscopy system users apply, twisting motions while connecting the blade in the HDMI port, or excessive torsion to the connection port, this force is transferred to the HDMI PCB, which may result in video synchronization interruption, loss of live image/blank screen, no cameras connected monitor warning, may present risk to patients, in which time to intubation is more critical.
FDA Determined
Cause 2
Device Design
Action On 06/05/20, Field Safety Notice/ URGENT:MEDICAL DEVICE RECALL notices were sent to customers. Customers were asked to do the following: - Review the information contained within this Field Safety Notice with all staff members who should be aware of the contents of the Field Safety Notice. - Discontinue use of all affected cables. - When replacements are received, destroy or return all affected cables in your possession. - Complete and return the recall response form. Customers with additional questions are encouraged to contact Customer Care agent support Monday through Friday from 6:00am to 4:00pm Pacific Time for the United States at (800) 331-2313 or email CSNotifications@verathon.com
Quantity in Commerce 437
Distribution Worldwide Distribution: US (nationwide) and countries of: Australia and United Kingdom.
Total Product Life Cycle TPLC 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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