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Terminated

Ventilator System Servo-i V3.1 Maquet Critical Care PC1771

FDA Recall Z-0379-2007 · Posted 2007-02-10

Recalling FirmMAQUET Inc.
Recall StatusTerminated
Product CodeCBK
Date Initiated2006-05-23
Date Terminated2009-03-23
Product Quantity2,436 units

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

Firm 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

Root Cause

Other

Distribution Pattern

Worldwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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