Ventilator System Servo-i V3.1 Maquet Critical Care PC1771
FDA device recall Z-0379-2007 · posted 2007-02-10 · Terminated
Recall details
- Recalling firm
- MAQUET Inc.
- Reason for recall
- The Connection of certain nebulizers to the built in driver has lead to reduced or no nebulization effect on the Servo-i Ventilator
- Action taken
- 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
- Root cause
- Other
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 2,436 units
- Distribution
- Worldwide
- Date initiated
- 2006-05-23
- Date posted
- 2007-02-10
- Date terminated
- 2009-03-23
- Location
- Bridgewater, NJ
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