Recall Z-1844-2014— Nellcor Puritan Bennett Inc. (dba Covidien LP)
Class II · Terminated
Class II FDA medical device recall by Nellcor Puritan Bennett Inc. (dba Covidien LP), initiated 2014-06-03, terminated 2016-08-22. It names one FDA 510(k) clearance: K970460. Product: Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. It is used in hospitals and healthcare facilities.. Reason: Covidien is conducting a medical device field correction for specific Puritan Bennett 840 Ventilators due to customer reports of loss of graphical user interface (GUI) display information while the ventilator continues to provide breath support..
- Recalling firm
- Nellcor Puritan Bennett Inc. (dba Covidien LP)
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-06-03
- Terminated
- 2016-08-22
- Firm location
- Boulder, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. It is used in hospitals and healthcare facilities.
Reason for recall
Covidien is conducting a medical device field correction for specific Puritan Bennett 840 Ventilators due to customer reports of loss of graphical user interface (GUI) display information while the ventilator continues to provide breath support.
Data sourced from openFDA. This site is unofficial and independent of the FDA.