Datex-Ohmeda Cardiocap/5 Patient Monitors
FDA device recall Z-0143-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Datex-Ohmeda Inc
- Reason for recall
- Datex-Ohmeda Cardiocap/5 Patient Monitors have bracket pins which do not adequately secure them to their optional mounting stand so the monitors may fall.
- Action taken
- Recall letters dated October 15, 2003 were sent to the consignees on 10/17/03. The letters request that the consignees order service kits to correct the units and use the kits to make the corrections of the devices.
- Root cause
- Other
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 875 units
- Distribution
- The monitors were shipped to consignees located nationwide in the United States and to foreign consignees located worldwide.
- Date initiated
- 2003-10-17
- Date posted
- 2004-07-20
- Date terminated
- 2005-11-15
- Location
- Madison, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES (K012837) | Datex-Ohmeda | 2001-09-14 |
| DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES (K992323) | Datex-Ohmeda, Inc. | 1999-11-01 |