Servo-Ventilator, SV300/300A, Part numbers 6070391 and 6424704. The Safety Alert action targets customers with Unit Seri
FDA device recall Z-0571-05 · posted 2005-03-08 · Terminated
Recall details
- Recalling firm
- Maquet Inc
- Reason for recall
- Failures of the air and oxygen gas modules occurred because of misuse/non-compliance of directions.
- Action taken
- Customer letter mailed on January 3, 2005 via certified postage, with return self-addressed postcards that customers must complete to acknowledge receipt of the instructions to refer to their Service and Operating Manuals.
- Root cause
- Other
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 7920 units
- Distribution
- The ventilators were distributed to hospitals nationwide. There are 33 VA Medical Center and DOD hospitals nationwide.
- Date initiated
- 2005-01-03
- Date posted
- 2005-03-08
- Date terminated
- 2005-09-08
- Location
- East Bridgewater, 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 |