Class 2 Device Recall Inogen One

• Date Initiated by Firm: August 01, 2005
• Date Posted: August 12, 2005
• Recall Status: Terminated on February 13, 2007
• Recall Number: Z-1368-05
• Recall Event ID: 32735
• 510(K)Number: K032818
• Product Classification: Generator, Oxygen, Portable - Product Code CAW
• Product: Portable Oxygen Generator
• Code Information: All codes.
• Recalling Firm/ Manufacturer: Inogen, Inc; 120 Cremona Dr Ste B; Goleta CA 93117-5564
• For Additional Information Contact: John Wells; 805-562-0507
• Manufacturer Reason for Recall: Firm plans to upgrade all units to correct situations that could lead to interuption in oxygen delivery.
• FDA Determined Cause: Other
• Action: Recall 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.
• Quantity in Commerce: 900
• Distribution: Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CAW