Newport e360 Ventilator, Model Number: e360 The e360 Ventilator System is intended to provide continuous (endotracheal o
FDA device recall Z-2468-2011 · posted 2011-06-08 · Terminated
Recall details
- Recalling firm
- Newport Medical Instruments Inc
- Reason for recall
- Cregarding e360 ventilators that were shipped with a different software version from what the customers ordered.
- Action taken
- 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 additional information, please call (714) 427-5811 extension 344.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 18
- Distribution
- Worldwide Distribution--USA (nationwide) including states of CA, KY, and Silver City, New Mexico and country of Quito, Ecuador.
- Date initiated
- 2009-10-27
- Date posted
- 2011-06-08
- Date terminated
- 2011-06-08
- Location
- Costa Mesa, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEWPORT E360 VENTILATOR (K053502) | Newport Medical Instruments, Inc. | 2006-01-10 |