Maquet Servo Ventilator 300/300A (SV300) Siemens - Elema AB,
FDA device recall Z-0588-2010 · 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
- 20837 (7847 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 300A (K970839) | Siemens Elema AB | 1997-10-14 |
| SERVO VENTILATOR 300 (K902859) | Siemens Life Support Systems | 1991-04-26 |