Nellcor Puritan Bennett Inc. (dba Covidien LP): Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.

Recall number

Z-0112-2015

Recalling firm

Nellcor Puritan Bennett Inc. (dba Covidien LP)

Product

Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.

Status

Terminated

Initiated

2014-10-01

Posted

2014-10-28

Terminated

2016-05-02

Reason

A software issue may lead to ventilator inoperative situations.

Root cause

Software design

Action

The firm sent Urgent: Field Correction Action letters, dated October 3, 2014, to consignees. The letter identified the affected product and the reason for the recall. Customers were provided actions to be taken, as well as, important safety reminders. The letter informed customers that they may continue to use their ventilators pending the software correction as long as two gas sources are connected to the ventilator at all times. Customers are to complete the attached acknowledgement and receipt form and fax it to Covidien at the number provided. For further assistance, customers are to contact the Technical Support Department at 1-800-255-6774.

Quantity

324 units

Distribution

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

Lot, serial or model codes

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, and 35B1400543.

510(k) numbers

K131252

PMA numbers

not on file

Product code

CBK

Firm FEI

2936999

Firm city

Boulder

Firm state

CO

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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