Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be used by heal
FDA device recall Z-0230-2016 · posted 2015-11-19 · Terminated
Recall details
- Recalling firm
- Event Medical LTD
- Reason for recall
- A component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming.
- Action taken
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 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 E
- Date initiated
- 2015-10-13
- Date posted
- 2015-11-19
- Date terminated
- 2017-06-22
- Location
- Lake Forest, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INSPIRATION VENTILATOR SYSTEM 5I/7I (K130178) | eVent Medical, Ltd. | 2013-10-29 |