Covidien Puritan Bennett 980 Ventilator recall: Software Issue
Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous…
Why was Covidien Puritan Bennett 980 Ventilator recalled?
A software issue may lead to ventilator inoperative situations.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous…
- Recalling firm
- Nellcor Puritan Bennett Inc. (dba Covidien LP)
- 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.
- Recall date
- November 5, 2014
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)