GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope system (...

FDA Device Recall #Z-1035-2016 — Class I — January 29, 2016

Recall Summary

Recall Number Z-1035-2016
Classification Class I — Serious risk
Date Initiated January 29, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Verathon, Inc.
Location Bothell, WA
Product Type Devices
Quantity 7733 units (6377 units in the US and 1356 units International)

Product Description

GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope system (GlideScope Titanium System) consists of a sterile-packaged, single-use video laryngoscope, multi-use Smart Cable and portable GlideScope video monitor. The system incorporates a high-resolution, full-color digital camera and monitor for real-time viewing and recording. Affected Product Names and Part Numbers: -LoPro S3: 0574-0130 (single blade) or 0270-0769 (box of 10) -LoPro S4: 0574-0131 (single blade) or 0270-0770 (box of 10) -MAC S3: 0574-0132 (single blade) or 0270-0771 (box of 10) -MAC S4: 0574-0133 (single blade) or 0270-0772 (box of 10) The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures.

Reason for Recall

The firm has become aware of the potential for disruption (flickering) in the video laryngoscopy image when GlideScope Titanium SU laryngoscope blades are in use. Video "flickering" appears as the intermittent break-up of the on-screen video image, appearing as either distorted horizontal or vertical bars of displaced video signal.

Distribution Pattern

Worldwide Distribution - US (nationwide) and to countries of: Australia, Belgium, Canada, Denmark, France, Germany, Hong Kong, Italy, Luxembourg, Saudi Arabia, Singapore, Spain, Sweden, The Netherlands, U.A.E., and United Kingdom.

Lot / Code Information

LOT Number ranges: -LoPro S3: 081814 - 093015; -LoPro S4: 081114 - 090315; -MAC S3: 080814 - 101315; -MAC S4: 022514 - 082115;

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-2476-2020 Class I GlideScope Core OneTouch Smart Cable, REF: 0800... Jun 5, 2020

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.