Servo-i Ventilator
FDA device recall Z-0878-05 · posted 2005-06-08 · Terminated
Recall details
- Recalling firm
- Maquet Inc
- Reason for recall
- Complaints about batteries indicating a satisfying remaining time but after a short time suddenly shut off without giving alarms to indicate short remaining battery back-up time. (Power off alarm will be given).
- Action taken
- Maquet sent out a Safety alert Letter on 3/31/2005 to all users of the Servo-i.
- Root cause
- Other
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 4379 units
- Distribution
- The ventilators were distributed nationwide to hosptials and clinics.
- Date initiated
- 2005-03-24
- Date posted
- 2005-06-08
- 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-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E (K040221) | Maquet Critical Care AB | 2004-02-20 |