Recall Z-2468-2011 ยท CBK Ventilator, Continuous, Facility Use
Newport Medical Instruments Inc
Newport e360 Ventilator, Model Number: e360 The e360 Ventilator System is intended to provide continuous (endotracheal or tracheostomy [ET] tube) or non-continuous (mask) ventilatory support and monitoring for infant, pediatric, and adult patients requiring tidal volumes equal to or greater than 20 milliliters (mL). The device is for use by prescription only. The intended environments include hos
| Date | Jun 8, 2011 (initiated Oct 27, 2009) |
| Status | Terminated |
| Reason | Cregarding e360 ventilators that were shipped with a different software version from what the customers ordered. |
| Root cause | Mixed-up of materials/components |
| Action | Newport Medical Instruments Inc. initiated a field correction on October 27, 2009, to address complaints received regarding e360 ventilators that were shipped with a different software version from what the customers ordered. Newport Medical Instruments provided the correct software to the Newport sales or service providers who were responsible for the units affected. They installed the correct software into the ventilators at the customer sites. No written Correction Notice was provided since the corrections were done at the customers' request. Should you have any questions or require addi |
| Quantity | 18 |
| Distribution | Worldwide Distribution--USA (nationwide) including states of CA, KY, and Silver City, New Mexico and country of Quito, Ecuador. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053502 | NEWPORT E360 VENTILATOR Newport Medical Instruments, Inc., Jan 10, 2006 |