Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2476-2020Class I

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

Verathon Inc. / initiated 2020-06-05 / Terminated / root cause: design

Verathon, Inc. began a recall of GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope Video Laryngoscope System Per PLRA: The Core OneTouch Cables (Reusable... on . FDA classified it as Class I and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2476-2020
Classification
Class I
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Verathon Inc.
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.
Product code
CCW Laryngoscope, Rigid
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.
Root cause tag
design
FDA root cause
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 [email protected]
Quantity in commerce
437
Distribution
Worldwide Distribution: US (nationwide) and countries of: Australia and United Kingdom.
Product codes and lots
All serial numbers

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2476-2020
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2476-2020Class ITerminatedVoluntary: Firm initiated