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.
FDA Recall Z-0112-2015 · Posted 2014-10-28
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Recalling FirmNellcor Puritan Bennett Inc. (dba Covidien LP)
Recall StatusTerminated
Product CodeCBK
Date Initiated2014-10-01
Date Terminated2016-05-02
Product Quantity324 units
Reason for Recall
A software issue may lead to ventilator inoperative situations.
Firm 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.
Root Cause
Software design
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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