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U.S. Department of Health and Human Services

Class 2 Device Recall Drive DeVilbiss iGo 2 Portable Oxygen Concentrator

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  Class 2 Device Recall Drive DeVilbiss iGo 2 Portable Oxygen Concentrator see related information
Date Initiated by Firm September 19, 2022
Date Posted November 11, 2022
Recall Status1 Open3, Classified
Recall Number Z-0229-2023
Recall Event ID 90950
510(K)Number K172648  
Product Classification Generator, oxygen, portable - Product Code CAW
Product 125 series iGO2 Portable Oxygen Concentrator-indicated for the
administration of supplemental oxygen.
Models: 125D, 125D-XB
Code Information UDI: 00885304022237 S/N: New Sales D22829087DS D22829097DS D22829092DS D22829086DS D22829156DS D22901205DS D22901207DS D22829099DS D22829161DS D22901203DS D22829157DS D22829159DS D22901204DS D22901201DS D22829096DS D22826095DS D22826079DS D22826091DS D22826086DS S/N: Repair D22829087DS D22829097DS D22829092DS D22829086DS D22829156DS D22901205DS D22901207DS D22829099DS D22829161DS D22901203DS D22829157DS D22829159DS D22901204DS D22901201DS D22829096DS D22826095DS D22826079DS D22826091DS D22826086DS
Recalling Firm/
Manufacturer		 DeVilbiss Healthcare LLC
100 Devilbiss Dr
Somerset PA 15501-2125
For Additional Information Contact same
800-338-1988
Manufacturer Reason
for Recall		 An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)
FDA Determined
Cause 2		 Under Investigation by firm
Action DeVilbiss notified Distributors/End Users by telephone on 9/19/22. Providers of portable oxygen concentrators, identified as recipient of affected units, were contacted asking them to return any finished good units in their possession with affected serial numbers to DeVilbiss for evaluation. A replacement unit will be provided once unit possession and shipping confirmation is received. If any unit has been supplied by the provider to an end user, the provider is being requested to contact the end user to request them to stop using the unit and to replace the unit immediately. If you have any questions, call 800-338-1988.
Quantity in Commerce 48 units
Distribution US Distribution in states of: CA, FL, OH, MI, MN, NY, PA, and TX; and (Foreign) country of: Canada.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = CAW and Original Applicant = DeVilbiss Healthcare, LLC
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