Recall Z-0647-2014 ยท CAW Generator, Oxygen, Portable
On Site Gas Systems Inc.
On Site Gas Systems POGS 33C Portable Oxygen Generation System
| Date | Jan 8, 2014 (initiated Dec 19, 2013) |
| Status | Terminated |
| Reason | Heat exchanger hose becomes weak and may fail. |
| Root cause | Device Design |
| Action | On Site Gas Systems issued letter on 12/19/13 and stated replacement parts to retrofit the blue Federal Heater hose with stainless steel will be provided and the letter included the Technical Bulletin TB 12-19-13-1 . |
| Quantity | 198 units |
| Distribution | US Distribution: PA only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.