Events

Recall of GlideScope Video Laryngoscope Reusable Blades (GVL, AVL)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Verathon, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71008
  • Event Risk Class
    Class 2
  • Event Number
    Z-0811-2016
  • Event Initiated Date
    2015-04-13
  • Event Date Posted
    2015-07-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135841
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Laryngoscope, rigid - Product Code CCW
  • Reason
    Verathon has revised the operations and maintenance manual (omm) to specifically state compatibility limitations of the reusable video laryngoscope blade validated through simulated use cycles, such that exceeding this number of cycles in the specific chemical agent may affect the potential life of the product.
  • Action
    Verathon sent an Urgent Medical Device Safety Alert letter dated April 13, 2015 and Safety Alert Reply Form to their consignees on April 17, 2015 Users are informed that Verathon implemented a Safety Alert regarding updates to the following Operations and Maintenance Manuals (OMM): " GVL Operations and Maintenance Manual: 0900-1204-08-60 " AVL Operations and Maintenance Manual: 0900-4200-02-60 For a copy of the most recent GVL or AVL Operations and Maintenance Manual, please visit http://verathon.com/support. If you have any questions regarding the Operations and Maintenance Manuals revisions noted above, please contact your Verathon representative or Verathon Customer Care at 800.331.2313 or 425.867.1348. You may also email customerservice@verathon.com. PLEASE NOTE: NO ADDITIONAL ACTIONS NEED TO BE TAKEN.

Device

GlideScope Video Laryngoscope Reusable Blades (GVL, AVL)
  • Model / Serial
    Affected GVL Reusable Blades Serial Numbers, by Part Number  GVL 3- 0574-0007: MD131859- MD151622; GVL 4- 0574-0001: LG131994- LG151773; GVL 5- 0574-0030: XL131577- XL151524.  Affected AVL Reusable Blades Serial Numbers, by Part Numbers:  AVL 2- 0574-0118: AC131852- AC151510; AVL 3- 0574-0115: AD131589- AD151506;  AVL 4- 0574-0116: AE131586- AE151558; AVL 5- 0574-0117: AF131503- AF151500.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5). || GVL: The GlideScope Video Laryngoscope 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. || AVL: The GlideScope AVL Video Monitor system has the same intended use as the GVL System. The difference between systems is that the AVL has a digital platform and the GVL an analog platform.
  • Manufacturer
    Verathon, Inc.

Manufacturer

Verathon, Inc.
  • Manufacturer Address
    Verathon, Inc., 20001 N Creek Pkwy, Bothell WA 98011-8218
  • Manufacturer Parent Company (2017)
    Roper Technologies Inc
  • Source
    USFDA