Recall Z-0478-2013— Verathon, Inc.
Class I · Terminated
Class I FDA medical device recall by Verathon, Inc., initiated 2012-10-25, terminated 2013-09-27. FDA's recall record names no specific 510(k) clearance for this event. Product: The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote monitor. It consists of a video laryngoscope and a portable video monitor. The affected GVL and Part numbers are GVL 3 0574-0007, GVL 4 0574-0001, and GVL 5 0574-0030. 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: Re-usable video laryngoscope blades of the GlideScope GVL3, GVL4, and GVL5 were recalled due to potential cracking..
- Recalling firm
- Verathon, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2012-10-25
- Terminated
- 2013-09-27
- Firm location
- Bothell, WA, United States
Product description
The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote monitor. It consists of a video laryngoscope and a portable video monitor. The affected GVL and Part numbers are GVL 3 0574-0007, GVL 4 0574-0001, and GVL 5 0574-0030. 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
Re-usable video laryngoscope blades of the GlideScope GVL3, GVL4, and GVL5 were recalled due to potential cracking.
Data sourced from openFDA. This site is unofficial and independent of the FDA.