Device product
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.
Z-1035-2016
Product summary
- Firm
- Verathon, Inc.
- Event
- Event 73014
- Status
- Terminated
- Classification
- Class I
- Quantity
- 7733 units (6377 units in the US and 1356 units International)
- Official record key
device-enforcement:Z-1035-2016
Official wording
Reason: 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.
Code information: LOT Number ranges: -LoPro S3: 081814 - 093015; -LoPro S4: 081114 - 090315; -MAC S3: 080814 - 101315; -MAC S4: 022514 - 082115;
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.
Derived failure modes
-
Unknown
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.