Recall Z-0230-2016 ยท CBK Ventilator, Continuous, Facility Use
Event Medical LTD
Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intra-hospital transport.
| Date | Nov 19, 2015 (initiated Oct 13, 2015) |
| Status | Terminated |
| Reason | A component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming. |
| Root cause | Component design/selection |
| Action | eVent Medical sent an Urgent Field Safety Notice dated October 12, 2015, to all affected customers on October 13, 2015, to inform them that eVent Medical is recalling Inspiration Ventilators i Series and LS 12.1 LCD because a component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming. The letter provides the customers with the problems identified and the actions to be taken. Customers with questions are instructed to call (949) 900-1917, x232. |
| Quantity | 6441 units total (251 units in US) |
| Distribution | Worldwide Distribution - US (Nationwide) and Internationally to: Algeria Argentina Australia Austria Bahrain Bangladesh Barbados Belarus Belgium Bolivia Canada Chile China Colombia Czech Rep Ecuador Egypt England Estonia Finland Germany Ghana Gibraltar Greece Guatemala Holland Hong Kong Hungary Indi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130178 | INSPIRATION VENTILATOR SYSTEM 5I/7I eVent Medical, Ltd., Oct 29, 2013 |