Maquet Servo Ventilator SV900C/D/E (SV900) Siemens-Elema AB, Solna, Sweden
FDA device recall Z-0589-2010 · posted 2010-01-05 · Terminated
Recall details
- Recalling firm
- MAQUET Inc.
- Reason for recall
- Some Servo Ventilators 300/300A and Servo Ventilator 900C/D/E should not be used with a system that may generate negative pressure below -100 cm H2O (Closed system suctioning) due to the risk of damaging the ventilator's pressure transducers.
- Action taken
- Maquet sent Device Correction letters commencing 11/17/09 and ending 11/23/09 by Federal Express.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 29364 (8438 of those in US)
- Distribution
- Worldwide distribution
- Date initiated
- 2009-11-17
- Date posted
- 2010-01-05
- Date terminated
- 2012-06-04
- Location
- Wayne, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SERVO VENTILATOR 900E (K884520) | Siemens-Elema Ventilation Systems | 1989-01-17 |
| ACCULEVEL CARBAMAZEPINE TEST (K871254) | Syva Co. | 1987-06-17 |