Recall Z-0018-05 ยท NWI Electrosurgical Electrode Kit
Datascope Corp
Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).
| Date | Oct 13, 2004 (initiated Sep 24, 2004) |
| Status | Terminated |
| Reason | Software anomaly where the variable heart rates may be displayed inaccurately or intermittent 'dashes' may be displayed when the patient's heart rate is derived from ECG. |
| Root cause | Other |
| Action | Letter was sent on 9/24/2004 via FedEx to the three customers with proof of delivery required. |
| Quantity | 19 |
| Distribution | Shipments made to three locations. These are Medstone Internation, Aliso Viejo, CA; Indiana Eye Clinic, Greenwood, IN; and Sumter Urologoly Assoc., Sumter, SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032338 | TRIO MONITOR MODEL 0998-00-0600 Datascope Corp., Feb 11, 2004 |