Recall Z-0611-03 ยท DPZ Oximeter, Ear
Datex-Ohmeda
Datex-Ohmeda Cardiocap/5 Anesthesia Monitor with N-XOSAT SpO2 measurement option
| Date | Mar 5, 2003 (initiated Sep 16, 2002) |
| Status | Terminated |
| Reason | Falsely high blood oxygen saturation readings in some circumstances which 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 | 85 |
| Distribution | Nationwide in the United States and worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012837 | MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES Datex-Ohmeda, Sep 14, 2001 |