Datex-Ohmeda Cardiocap/5 Anesthesia Monitor with N-XOSAT SpO2 measurement option
FDA device recall Z-0611-03 · posted 2003-03-05 · Terminated
Recall details
- Recalling firm
- Datex-Ohmeda
- Reason for recall
- Falsely high blood oxygen saturation readings in some circumstances which could result in no alarm in a critical life-threatening situation.
- Action taken
- 'Medical Device Advisory Notice' letters dated September 16, 2002 were sent to the consignees, gave recommendations about alternative monitoring for certain patients, and stated that there would be a field correction to reduce the possibility of the problem.
- Root cause
- Other
- Status
- Terminated
- Product code
- DPZ
- Quantity affected
- 85
- Distribution
- Nationwide in the United States and worldwide.
- Date initiated
- 2002-09-16
- Date posted
- 2003-03-05
- Date terminated
- 2004-07-02
- 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 |