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U.S. Department of Health and Human Services

Class 2 Device Recall GlideScope Video Laryngoscope Reusable Blades (GVL, AVL)

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 Class 2 Device Recall GlideScope Video Laryngoscope Reusable Blades (GVL, AVL)see related information
Date Initiated by FirmApril 13, 2015
Date PostedJuly 13, 2015
Recall Status1 Terminated 3 on October 26, 2016
Recall NumberZ-0811-2016
Recall Event ID 71008
Product Classification Laryngoscope, rigid - Product Code CCW
ProductGlideScope 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.
Code Information 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.  
Recalling Firm/
Manufacturer		 Verathon, Inc.
20001 N Creek Pkwy
Bothell WA 98011-8218
For Additional Information ContactCustomer Service
425-867-1348
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionVerathon 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.
Quantity in Commercetotal 9088 units ( 5786 units in the US and 3302 units International)
DistributionWorldwide Distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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