Power cord manufactured by ElectriCord Manufacturing Company , P/N 316579, used with DINAMAP Patient Monitors as Follows
FDA device recall Z-0011-04 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- GE Medical Systems Information Technologies
- Reason for recall
- Reports of broken plug ground pins on AC power cords for patient monitors.
- Action taken
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- MWI
- Quantity affected
- 16,339 Power Cords
- Distribution
- The recalled AC power cords were distributed to approximately 2600 Domestic hospital accounts nationwide and 180 international accounts.
- Date initiated
- 2003-04-30
- Date posted
- 2003-10-15
- Date terminated
- 2012-05-03
- Location
- Tampa, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N (K021435) | Ge Medical Systems Information Technologies | 2002-05-22 |
| DINAMAP PRO 1000 MONITOR, MODEL 1000 (K012915) | Ge Medical Systems Information Technologies | 2002-03-21 |
| DINAMAP PRO SERIES MONITOR, MODELS 110, 210, 310, 410 (K020022) | Ge Medical Systems Information Technologies | 2002-02-01 |