Newport e360 Ventilator, Rx only. The e360 Ventilator System is intended to provide continuous (endotracheal or tracheos

FDA device recall Z-2029-2009 · posted 2009-09-04 · Terminated

Recall details

Recalling firm

Newport Medical Instruments Inc

Reason for recall

In December 2008, Newport initiated a field correction to upgrade e360 ventilators with software versions 3.0 or higher to software version 3.3. As a result of this upgrade, some customers experienced unexpected device alert alarms. Newport's investigation into these complaints confirmed that the 3.3 software responds too quickly to certain situations, giving a false device alert. Newport condu

Action taken

Newport Medical initally sent out a Field Correction Notice to a limited number consignees dated December 17, 2008 and then the notice was expanded to include all e360 consignees dated June 15, 2009. The firm notified consignees that they have revised the e360 software to version 3.8. A customer verification form was attached to verify upgrade completion. For further questions, contact Newport Customer Technical Support Department at 1-800-451-3111 or +1-714-427-5811 Extension 500.

Root cause

Software design

Status

Terminated

Product code

CBK

Quantity affected

4,117 units (214 Domestically; 3,903 Internationally)

Distribution

Worldwide Distribution -- US (including AL, AZ, CA, CO, FL, GA, IL, IN, KY, MA, MD, ME, MI, NJ, NM, NY, OH, OK, OR, PA, UT and VA), Albania, Algeria, Argentina, Armenia, Australia, Austria, Bangladesh

Date initiated

2008-12-15

Date posted

2009-09-04

Date terminated

2011-11-04

Location

Costa Mesa, CA

Related 510(k) clearances