Device product
125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
Z-0229-2023
Product summary
- Event
- Event 90950
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 48 units
- Official record key
device-enforcement:Z-0229-2023
Official wording
Reason: An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)
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
Distribution pattern: US Distribution in states of: CA, FL, OH, MI, MN, NY, PA, and TX; and (Foreign) country of: Canada.
Derived failure modes
-
Unknown
An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)