Datex-Ohmeda S/5 Oxygen Saturation Module (M-OSAT)
FDA device recall Z-0610-03 · posted 2003-03-05 · Terminated
Recall details
- Recalling firm
- Datex-Ohmeda
- Reason for recall
- Falsely high blood oxygen saturation readings in some circumstances 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
- DQA
- Quantity affected
- 1019
- 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 |
|---|---|---|
| DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCE (K011670) | Datex-Ohmeda | 2001-06-26 |
| DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES (K010463) | Datex-Ohmeda, Inc. | 2001-03-15 |