Recall Z-0248-2020 ยท CAW Generator, Oxygen, Portable
Caire, Inc.
SAROS Oxygen System Model 3000
| Date | Sep 16, 2019 |
| Status | Terminated |
| Reason | There is an electronics control issue that causes the unit to not power on with battery power only. |
| Root cause | Nonconforming Material/Component |
| Action | The firm initiated the recall by email on 09/16/2019. The firm explained the issue and requested the return of the units. |
| Quantity | 10 units |
| Distribution | US and Chile |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083163 | OMNI 2 OXYGEN SYSTEM Sequal Technologies, Inc., Oct 20, 2009 |