Z-0379-2007

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

Name: Z-0379-2007 Ventilator System Servo-i V3.1 Maquet Critical Care PC1771
Creator: MAQUET Inc.
Published: 2006-05-23
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2006-05-23 / Terminated

FDA source

MAQUET Inc. began a recall of Ventilator System Servo-i V3.1 Maquet Critical Care PC1771 on 2006-05-23. The reason FDA records is "The Connection of certain nebulizers to the built in driver has lead to reduced or no nebulization effect on the Servo-i Ventilator". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0379-2007
Status: Terminated
Initiated: 2006-05-23
Posted: 2007-02-10
Terminated: 2009-03-23
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Ventilator System Servo-i V3.1 Maquet Critical Care PC1771
Product code: CBK Ventilator, Continuous, Facility Use
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
FDA 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 in commerce: 2,436 units
Distribution: Worldwide
Product codes and lots: Article number 64-87-800---Serial Numbers 14000-22772

Product code CBK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)