Recall Z-0929-04 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Hudson Respiratory Care Inc
Concha IV Plus Heated Humidifier
| Date | Jul 20, 2004 (initiated Apr 20, 2004) |
| Status | Terminated |
| Reason | Software malfunction. The humidifier did not retain the clinician selected default settings for temperature gradient, after the unit had been placed in the "pause" mode. |
| Root cause | Other |
| Action | Firm will call hospitals to arrange for a visit to update the software. |
| Quantity | 1049 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.