GE Medical Systems Information Technologies
Critikon brand Omni-Stat Finger Sensor - P/N 009084
| Date | Oct 15, 2003 (initiated Nov 16, 2000) |
| Status | Terminated |
| Reason | Instructions for use contained incorrect sensor reference. |
| Root cause | Other |
| Action | A recall notification letter with the correct 'Instructions for Use' attached, was mailed certified return receipt requested to accounts on 11/16/2000. Follow-up contact was made by mail or telephone until 100% response was completed. No return of product was requested but rather users were provided with the correct instructions for use. |
| Quantity | Total of 481 |
| Distribution | Product was distributed to 69 domestic hospitals nationwide including four military accounts. Also product was distributed 6 accounts in Canada, one in Thailand, one in Chile, one in Japan and one in singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K925542 | OXYSHUTTLE II ,MODIFICATION Sensor Medics Corp., Feb 17, 1993 |