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U.S. Department of Health and Human Services

Class 1 Device Recall Puritan Bennett

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  Class 1 Device Recall Puritan Bennett see related information
Date Initiated by Firm October 01, 2014
Date Posting Updated December 09, 2014
Recall Status1 Terminated 3 on July 01, 2016
Recall Number Z-0180-2015
Recall Event ID 69324
510(K)Number K131252  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
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.
Recalling Firm/
Nellcor Puritan Bennett Inc. (dba Covidien LP)
6135 Gunbarrel Ave
Boulder CO 80301-3214
For Additional Information Contact Mr. Michael A. Ronningen
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Device Design
Action Update: Consignees were notified on 12/11/14 of strategy change after Covidien sent an Urgent Field Safety Corrective Action notification with instructions dated September 2014 via traceable courier to affected consignees. The letter identifed the affected product, problem and actions to be taken. Consignees were instructed to complete the attached verification form and fax it to the Covidien RMS contact indicated on the form. If you need further assistance, contact the Technical Support Department @ 1-800-255-6774, option 4, then option 1.
Quantity in Commerce 324 units
Distribution 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.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = COVIDIEN