Skip to content
Recall Observatory FDA recall evidence

Device product

Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.

Z-0180-2015

October 01, 2014

Class I

Product summary

Firm
Nellcor Puritan Bennett Inc. (dba Covidien LP)
Event
Event 69324
Status
Terminated
Classification
Class I
Quantity
324 units
Official record key
device-enforcement:Z-0180-2015

Official wording

Reason: Covidien is recalling certain Puritan Bennett 980 Ventilator Systems due to a blacklight inverter PCBA where a capacitor component can fail, causing a dim but functional screen and thermal odor.

Code information: Model number PB980 Ventilator:35B1400143, 35B1400684, 35B1400627, 35B1400708, 35B1400398, 35B1400482, 35B1400491, 35B1400512, 35B1400601, 35B1400121, 35B1400568, 35B1400590, 35B1400595, 35B1400599, 35B1400606, 35B1400106, 35B1400146, 35B1400169, 35B1400226, 35B1400260, 35B1400270, 35B1400263, 35B1400351, 35B1400373, 35B1400400, 35B1400401, 35B1400608, 35B1400089, 35B1400112, 35B1400683, 35B1400685, 35B1400678, 35B1400118, 35B1400114, 35B1400355, 35B1400144, 35B1400300, 35B1400379, 35B1400412, 35B1400472, 35B1400489, 35B1400490, 35B1400492, 35B1400493, 35B1400499, 35B1400500, 35B1400501, 35B1400502, 35B1400507, 35B1400577, 35B1400207, 35B1400211, 35B1400216, 35B1400222, 35B1400225, 35B1400231, 35B1400267, 35B1400312, 35B1400323, 35B1400340, 35B1400383, 35B1400128, 35B1400363, 35B1400459, 35B1400589, 35B1400616, 35B1400637, 35B1400483, 35B1400311, 35B1400447, 35B1400648, 35B1400651, 35B1400654, 35B1400662, 35B1400686, 35B1400692, 35B1400175, 35B1400294, 35B1400436, 35B1400485, 35B1400586, 35B1400644, 35B1400687, 35B1400689, 35B1400694, 35B1400700, 35B1400661, 35B1400676, 35B1400693, 35B1400732, 35B1400734, 35B1400736, 35B1400737, 35B1400742, 35B1400280, 35B1400360, 35B1400471, 35B1400609, 35B1400674, 35B1400688, 35B1400755, 35B1400480, 35B1400675, 35B1400706, 35B1400771, 35B1400667, 35B1400704, 35B1400705, 35B1400727, 35B1400743, 35B1400279, 35B1400285, 35B1400262, 35B1400265, 35B1400259, 35B1400494, 35B1400403, 35B1400779, 35B1400783, 35B1400509, 35B1400724, 35B1400763, 35B1400767, 35B1400566, 35B1400768, 35B1400772, 35B1400791, 35B1400793, 35B1400817, 35B1400525, 35B1400796, 35B1400801, 35B1400809, 35B1400821, 35B1400828, 35B1400333, 35B1400366, 35B1400392, 35B1400440, 35B1400463, 35B1400478, 35B1400308, 35B1400347, 35B1400367, 35B1400396, 35B1400078, 35B1400099, 35B1400130, 35B1400155, 35B1400157, 35B1400158, 35B1400174, 35B1400176, 35B1400178, 35B1400180, 35B1400281, 35B1400315, 35B1400631, 35B1400635, 35B1400625, 35B1400653, 35B1400843, 35B1400847, 35B1400233, 35B1400271, 35B1400337, 35B1400350, 35B1400359, 35B1400368, 35B1400384, 35B1400468, 35B1400486, 35B1400495, 35B1400094, 35B1400236, 35B1400437, 35B1400438, 35B1400479, 35B1400496, 35B1400505, 35B1400506, 35B1400427, 35B1400511, 35B1400325, 35B1400462, 35B1400514, 35B1400536, 35B1400537, 35B1400544, 35B1400066, 35B1400200, 35B1400782, 35B1400829, 35B1400015, 35B1400110, 35B1400516, 35B1400517, 35B1400859, 35B1400013, 35B1400103, 35B1400167, 35B1400124, 35B1400007, 35B1400058, 35B1400083, 35B1400129, 35B1400132, 35B1400006, 35B1400079, 35B1400113, 35B1400116, 35B1400219, 35B1400163, 35B1400543.

Distribution pattern: Worldwide Distribution-US (nationwide) including the states of CA, CO, FL, GA, KY, MA, MN, NC, NY, OH, OK, PA, SC, TN, TX, UT, and WI, and the countries of Canada, Mexico, Saudi Arabia, South Africa and United Arab Emirates.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Covidien is recalling certain Puritan Bennett 980 Ventilator Systems due to a blacklight inverter PCBA where a capacitor component can fail, causing a dim but functional screen and thermal odor.