The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1035-2016·Announced 2016-03-16

Verathon Recalls GlideScope Titanium Video Laryngoscope Blades Due to Image Flickering

Verathon is recalling GlideScope Titanium single-use video laryngoscope blades because the video image may flicker or distort during use.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"

Plain-English summary

Verathon, Inc. is recalling the GlideScope Titanium Single-Use Video Laryngoscope blades. The recall involves 7,733 units, including 6,377 units in the United States and 1,356 units distributed internationally to countries including Australia, Belgium, Canada, Denmark, France, Germany, Hong Kong, Italy, Luxembourg, Saudi Arabia, Singapore, Spain, Sweden, The Netherlands, the U.A.E., and the United Kingdom.

The firm identified a potential for disruption, specifically flickering, in the video laryngoscopy image when the blades are in use. This video flickering appears as an intermittent break-up of the on-screen video image, manifesting as distorted horizontal or vertical bars of displaced video signal. The affected product is intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures.

The affected part numbers include LoPro S3 (0574-0130, 0270-0769), LoPro S4 (0574-0131, 0270-0770), MAC S3 (0574-0132, 0270-0771), and MAC S4 (0574-0133, 0270-0772). The lot number ranges for these products are: LoPro S3 (081814 - 093015), LoPro S4 (081114 - 090315), MAC S3 (080814 - 101315), and MAC S4 (022514 - 082115).

The recalled product

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…
Manufacturer
Verathon, Inc.
Category
Medical Device — Surgical Instruments
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

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

Distribution

Distributed nationwide across the United States.

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