Recall Z-0063-06 ยท DSI Detector And Alarm, Arrhythmia
Spacelabs Medical Incorporated
Tru-Link DIN unshielded ECG cable, 5-lead
| Date | Nov 3, 2005 (initiated Sep 16, 2005) |
| Status | Terminated |
| Reason | ECG 5-lead cable miswired - A physician could interpret the incorrect polarities as a conduction defect. |
| Root cause | Other |
| Action | On 9/16/05 the firm sent a letter to their customers advising of the problem. The customer was requested to check the code on their cables, and if the suspect code, discard the cable. The customer was provided a response sheet to indicate they received the notification and to request new cables. |
| Quantity | 632 cables |
| Distribution | Cables were distributed to 9 US hospitals/medical centers and 30 international customers. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K842616 | SPACELABS ALPHA PC PATIENT COMPUTER Spacelabs, Inc., Oct 18, 1984 |