Recall Z-0379-2007 ยท CBK Ventilator, Continuous, Facility Use
MAQUET Inc.
Ventilator System Servo-i V3.1 Maquet Critical Care PC1771
| Date | Feb 10, 2007 (initiated May 23, 2006) |
| Status | Terminated |
| Reason | The Connection of certain nebulizers to the built in driver has lead to reduced or no nebulization effect on the Servo-i Ventilator |
| Root cause | Other |
| Action | Maquet Critical Care issued an ''Extended Warranty'' letter on 5/23/2006. On March 13, 2007, Maquet modified its recall strategy and issued a Recall Notification letter accompanied by a Safety Alert letter to all customers with Servo-i ventilators, serial numbers in the 14000-22772 range, with Servo nebulizer installed. The Safety Alert letter provides customers with information on how to identify if the unit is affected, and how to identify if the unit has shown any failures, as well as, any precautions. Firm initiated recall is on-going |
| Quantity | 2,436 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.