Recall Z-1577-2014— 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 2014-04-18, terminated 2016-03-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number SBC2105A. Intended to provide invasive or noninvasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency.. Reason: Reports of the audible alarm not sounding when the ventilator is in an alarm state. The ventilator, as well as the visual and remote alarms, continue to operate normally..
- Recalling firm
- Nellcor Puritan Bennett Inc. (dba Covidien LP)
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-18
- Terminated
- 2016-03-01
- Firm location
- Boulder, CO, United States
Product description
Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number SBC2105A. Intended to provide invasive or noninvasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency.
Reason for recall
Reports of the audible alarm not sounding when the ventilator is in an alarm state. The ventilator, as well as the visual and remote alarms, continue to operate normally.
Data sourced from openFDA. This site is unofficial and independent of the FDA.