ClearanceBrief
Recall Z-1368-05 ยท CAW Generator, Oxygen, Portable

Inogen, Inc

Portable Oxygen Generator

DateAug 12, 2005 (initiated Aug 1, 2005)
StatusTerminated
ReasonFirm plans to upgrade all units to correct situations that could lead to interuption in oxygen delivery.
Root causeOther
ActionRecall is scheduled to begin August 1st 2005 by letter to customers informing them that the units will be upgraded on a predetermined schedule. Firm estimates completion in 6 months.
Quantity900
DistributionNationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K032818INOGEN ONE OXYGEN CONCENTRATOR
Inogen, Inc., May 13, 2004