Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb).
FDA Recall Z-2329-2015 · Posted 2015-08-14
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Recalling FirmCovidien LP (formerly Nellcor Puritan Bennett Inc.)
Recall StatusTerminated
Product CodeCBK
Date Initiated2015-07-16
Date Terminated2016-06-02
Product Quantity657 units
Reason for Recall
Reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal Volume Control Plus (VC+) Mode with active humidification. This situation may potentially lead to respiratory compromise if not recognized.
Firm Action
Consignees will be notified via letter on July 17, 2015. No products will be returned, the reconfiguration of affected ventilators will occur at customer sites.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution-US (nationwide) and the countries of Canada, United Arab Emirates, Argentina, Australia, Bahrain, Brazil, Chile, Colombia, Costa Rica, Egypt, Ireland, Israel, Jordan, Japan, Kuwait, Lebanon, Morocco, Mexico, Panama, Peru, Qatar, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Turkey, and Uruguay.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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