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Recall Observatory FDA recall evidence

Device product

GlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115; AVL 4-0574-0116, AVL 5- 0574-0117. AVL is a video laryngoscope that incorporates a high resolution color camera, an LED light source and video output to a remote monitor. This system has a digital platform.

Z-0421-2016

November 30, 2015

Class II

Product summary

Firm
Verathon, Inc.
Event
Event 72642
Status
Terminated
Classification
Class II
Quantity
448 units (189 units in US and 259 units outside US)
Official record key
device-enforcement:Z-0421-2016

Official wording

Reason: Certain models and serial numbers of GlideScope GVL and AVL laryngoscope blades may separate, due to inadequate bonding of the silicone adhesive affixing the halves of the blade. The potential for blade separation may not be readily visible during routine inspection before or after intubation.

Code information: ***ADDITIONAL 23 SERIAL NUMBERS IN US AND INTERNATIONAL AS OF 12/31/15*** AD145054, AD151509, AD151510, AD151511, AD151512, AD151514, AD151516, AD151517, AD151518, AD151519, AD151520, AD151521, AD151522, AD151523, AD151526, AE151507, AE151529, AE151542, AE151543, AE151544, AF151517, AF151518, and AF151522. ****SERIAL NUMBERS OF UNITS IN THE US***************************************** AD141605, AD141610, AD141614, AD141615, AD141618, AD141621, AD141622, AD141623, AD141624, AD141646, AD141647, AD141651, AD141652, AD141653, AD141654, AD141655, AD141674, AD141684, AD145000, AD145001, AD145005, AD145006, AD145007, AD145008, AD145010, AD145011, AD145012, AD145013, AD145014, AD145015, AD145027, AD145028, AD145029, AD145030, AD145031, AD145035, AD145036, AD145037, AD145040, AD145041, AD145042, AD145043, AD145044, AD145045, AD145046, AD145047, AD145048, AD145050, AD145051, AD145052, AD145057, AD145064, AD145065, AD145066, AD145069, AD151504, AD151505, AD151535, AE141629, AE141631, AE141632, AE141633, AE141638, AE141639, AE141640, AE145011, AE145012, AE145013, AE145014, AE145015, AE145016, AE145017, AE145018, AE145019, AE145020, AE145021, AE145022, AE145023, AE145026, AE145027, AE145028, AE145032, AE145033, AE145034, AE145035, AE145036, AE145037, AE145038, AE145039, AE145040, AE146010, AE146011, AE146012, AE146013, AE146014, AE146015, AE146016, AE146017, AE146018, AE146019, AE146020, AE146021, AE146022, AE146023, AE146024, AE146025, AE146026, AE146027, AE146033, AE146034, AE146035, AE146036, AE146037, AE146038, AE146039, AE146040, AE146041, AE146042, AE146043, AE146047, AE146048, AE146051, AE146053, AE146054, AE151504, AE151505, AE151506, AE151513, AE151514, AE151515, AE151516, AE151517, AE151518, AE151519, AE151520, AE151522, AE151523, AE151524, AE151525, AE151526, AE151535, AE151538, AE151539, AE151540, AE151541, AF141570, AF141571, AF141580, AF141582, AF145006, AF145011, AF145015, AF146019, AF146029, AF146031, AF146032, AF146035, AF146036, AF146037, AF146038, AF151500, AF151502, AF151503, AF151504, AF151505, AF151506, AF151508, AF151510, AF151512, AF151515, and AF151516. ****SERIAL NUMBERS OF UNITS OUTSIDE THE US**************** AD141603, AD141604, AD141607, AD141608, AD141609, AD141611, AD141612, AD141613, AD141617, AD141619, AD141620, AD141625, AD141626, AD141627, AD141628, AD141629, AD141631, AD141632, AD141633, AD141634, AD141635, AD141636, AD141637, AD141638, AD141639, AD141640, AD141641, AD141642, AD141643, AD141644, AD141645, AD141648, AD141650, AD141656, AD141657, AD141658, AD141659, AD141660, AD141661, AD141662, AD141663, AD141664, AD141665, AD141666, AD141667, AD141668, AD141669, AD141670, AD141671, AD141672, AD141673, AD141675, AD141676, AD141677, AD141678, AD141679, AD141680, AD141681, AD141682, AD141683, AD145002, AD145003, AD145016, AD145017, AD145018, AD145019, AD145020, AD145021, AD145022, AD145023, AD145024, AD145025, AD145026, AD145032, AD145033, AD145034, AD145038, AD145039, AD145049, AD145053, AD145055, AD145056, AD145058, AD145059, AD145060, AD145061, AD145062, AD145063, AD145068, AD145070, AD145071, AD145072, AD146000, AD146002, AD146003, AD146004, AD146005, AD146006, AD146007, AD146008, AD146009, AD146010, AD146011, AD146012, AD146013, AD146014, AD146015, AD151500, AD151501, AD151502, AD151503, AD151506, AD151507, AD151508, AE141630, AE141634, AE141635, AE141636, AE141637, AE141641, AE141642, AE141643, AE141644, AE141645, AE141646, AE141647, AE141648, AE141649, AE141650, AE141652, AE141653, AE141654, AE141655, AE141656, AE141657, AE141664, AE141665, AE141666, AE141667, AE141668, AE141669, AE145000, AE145001, AE145002, AE145003, AE145004, AE145005, AE145006, AE145007, AE145008, AE145009, AE145025, AE145029, AE145030, ae145031, AE146000, AE146001, AE146003, AE146004, AE146006, AE146007, AE146008, AE146009, AE146028, AE146029, AE146031, AE146032, AE146044, AE146045, AE146046, AE146052, AE151500, AE151501, AE151502, AE151503, AE151508, AE151509, AE151510, AE151511, AE151512, AE151521, AE151527, AE151528, AE151532, AE151533, AE151534, AE151536, AE151537, AE151545, AF141572, AF141573, AF141579, AF141581, AF141583, AF141585, AF141586, AF141587, AF141588, AF141589, AF145000, AF145001, AF145002, AF145003, AF145005, AF145007, AF145008, AF145009, AF145010, AF145013, AF145014, AF145016, AF145017, AF145018, AF145019, AF145020, AF145021, AF146000, AF146001, AF146002, AF146003, AF146004, AF146005, AF146006, AF146007, AF146008, AF146009, AF146010, AF146011, AF146012, AF146013, AF146014, AF146015, AF146016, AF146017, AF146018, AF146020, AF146021, AF146022, AF146023, AF146024, AF146025, AF146026, AF146027, AF146028, AF146030, AF146033, AF146034, AF151501, AF151507, AF151513, AF151514, AF151520, AF151521, and AF151525.

Distribution pattern: Worldwide Distribution - US (nationwide including Puerto Rico) and Internationally to Bahrain, Belgium, Bermuda, Brunei Darussalam, Bulgaria, Canada, China , Czech Republic, Denmark, France, Georgia, Germany, Greece, India , Indonesia, Iran , Israel, Italy , Japan, Kuwait, Lebanon, Malaysia, Morocco, Palestinian Territories, Panama, Peru, Philippines, Republic of Serbia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, and U.A.E.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Certain models and serial numbers of GlideScope GVL and AVL laryngoscope blades may separate, due to inadequate bonding of the silicone adhesive affixing the halves of the blade. The potential for blade separation may not be readily visible during routine inspection before or after intubation.