Recall Z-0011-04 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
GE Medical Systems Information Technologies
Power cord manufactured by ElectriCord Manufacturing Company , P/N 316579, used with DINAMAP Patient Monitors as Follows: DINAMAP PRO Series, DINAMAP PRO 1000 Monitor under both the Critikon and GE Medical Systems. The company name EliectriCord is on the power cord plug.
| Date | Oct 15, 2003 (initiated Apr 30, 2003) |
| Status | Terminated |
| Reason | Reports of broken plug ground pins on AC power cords for patient monitors. |
| Root cause | Component design/selection |
| Action | The recalling firm mailed a Recall Notification Letter with response form and corretive power cords beginning on April 30, 2003 until August 14, 2003 as corrective cords became available. Consignees were instructed on how to determine if they have the recalled cords and to destroy any found by cutting the plug from the wire. Also corrective AC power cords were provided to each consignee. |
| Quantity | 16,339 Power Cords |
| Distribution | The recalled AC power cords were distributed to approximately 2600 Domestic hospital accounts nationwide and 180 international accounts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012915 | DINAMAP PRO 1000 MONITOR, MODEL 1000 Ge Medical Systems Information Technologies, Mar 21, 2002 |
| K020022 | DINAMAP PRO SERIES MONITOR, MODELS 110, 210, 310, 410 Ge Medical Systems Information Technologies, Feb 1, 2002 |
| K021435 | DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N Ge Medical Systems Information Technologies, May 22, 2002 |