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

FDA Device Recall #Z-2476-2020 — Class I — June 5, 2020

Recall Summary

Recall Number Z-2476-2020
Classification Class I — Serious risk
Date Initiated June 5, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Verathon, Inc.
Location Bothell, WA
Product Type Devices
Quantity 437

Product Description

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.

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.

Distribution Pattern

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

Lot / Code Information

All serial numbers

Other Recalls from Verathon, Inc.

Recall # Classification Product Date
Z-2022-2024 Class II Brand Name: GlideScope Core 15-inch FHD Model/... Apr 29, 2024
Z-2021-2024 Class II Brand Name: GlideScope Core 15-inch Monitor Mo... Apr 29, 2024
Z-2172-2021 Class III GlideScope Go Monitors Jul 1, 2021
Z-0531-2021 Class II BladderScan Prime Plus Probe REF 0570-0395 - Pr... Sep 29, 2020
Z-1471-2020 Class II GlideScope Video Laryngoscope, Operations & Mai... Mar 31, 2019

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.