GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope Video Laryngoscope System Per PLRA:

FDA device recall Z-2476-2020 · posted 2020-07-10 · Terminated

Recall details

Recalling firm

Verathon, Inc.

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.

Action taken

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

Root cause

Device Design

Status

Terminated

Product code

CCW

Quantity affected

437

Distribution

Worldwide Distribution: US (nationwide) and countries of: Australia and United Kingdom.

Date initiated

2020-06-05

Date posted

2020-07-10

Date terminated

2024-04-22

Location

Bothell, WA