Recall Z-0878-05 ยท CBK Ventilator, Continuous, Facility Use
Maquet Inc
Servo-i Ventilator
| Date | Jun 8, 2005 (initiated Mar 24, 2005) |
| Status | Terminated |
| Reason | 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). |
| Root cause | Other |
| Action | Maquet sent out a Safety alert Letter on 3/31/2005 to all users of the Servo-i. |
| Quantity | 4379 units |
| Distribution | The ventilators were distributed nationwide to hosptials and clinics. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040221 | SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E Maquet Critical Care AB, Feb 20, 2004 |