Recall Z-0497-2019 ยท CBK Ventilator, Continuous, Facility Use
COVIDIEN LLC
Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult Ventilator Puritan Bennett" 980 Neonatal Ventilator Puritan Bennett" 980 Universal Ventilator Product Usage: The Puritan Bennett 980 Series Ventilator is designed for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation and weigh a minimum
| Date | Dec 18, 2018 (initiated Sep 18, 2018) |
| Status | Terminated |
| Reason | Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) functionality and labeling of the scalar waveform displayed on GUI during ventilation |
| Root cause | Device Design |
| Action | Medtronic notified U.S. consignees notified via Federal Express or certified mail on September 19, 2018, and the letter informs customers that Medtronic has developed a software update, Maintenance Release (MR) 5.4. Medtronic Service Engineers will load the MR5.4 software during the next scheduled or planned maintenance visit. Immediately notify all care environments in which the PB980 ventilators are used about this notification. " If your facility has distributed PB980 ventilators to other persons or facilities, please promptly forward a copy of this letter to those recipients. " Complete |
| Quantity | 9,593 |
| Distribution | Worldwide Distribution - US Nationwide Foreign: Canada Argentina Chile Japan Hong Kong Taiwan Uruguay Austria Austria Azerbaijan Belgium Bosnia And Herzegovina Bulgaria Croatia Czech Republic France Germany Greece Hungary Ireland Israel Italy Kazakhstan Kenya Kuwait Latvia Lebanon Lithuania Netherla |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162738 | Puritan Bennett 980 Ventilator System Covidien, Oct 27, 2017 |