Recall Z-0610-03 ยท DQA Oximeter
Datex-Ohmeda
Datex-Ohmeda S/5 Oxygen Saturation Module (M-OSAT)
| Date | Mar 5, 2003 (initiated Sep 16, 2002) |
| Status | Terminated |
| Reason | Falsely high blood oxygen saturation readings in some circumstances could result in no alarm in a critical life-threatening situation. |
| Root cause | Other |
| Action | 'Medical Device Advisory Notice' letters dated September 16, 2002 were sent to the consignees, gave recommendations about alternative monitoring for certain patients, and stated that there would be a field correction to reduce the possibility of the problem. |
| Quantity | 1019 |
| Distribution | Nationwide in the United States and worldwide. |
| FDA record | Open on fda.gov |