Z-0372-2007

Ventilator System SERVO-i V3.1 PC1777 Maquet Critical Care

Name: Z-0372-2007 Ventilator System SERVO-i V3.1 PC1777 Maquet Critical Care
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 PC1777 Maquet Critical Care on 2006-05-23. The reason FDA records is "Reported failures of the SERVO-i ventilators user interface system causing technical errors and increased fault frequencies. Switches may be activated unintentionally, or a function not activate when the switch is...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0372-2007
Status: Terminated
Initiated: 2006-05-23
Posted: 2007-01-25
Terminated: 2008-04-11
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Ventilator System SERVO-i V3.1 PC1777 Maquet Critical Care
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Reported failures of the SERVO-i ventilators user interface system causing technical errors and increased fault frequencies. Switches may be activated unintentionally, or a function not activate when the switch is selected. Direct access knobs may not function or change the parameter in the wrong direction compared to how they are turned.
FDA root cause: Other
Action: Maquet sent an ''Extended Warranty'' letter on May 23, 2006. On March 13, 2007, Maquet issued a Recall Notification letter to all customers stating that they will replace all PC1777 boards in the serial number range 2400-3300, which have not previously been replaced. A safety alert letter was included outlining the failure indication and effect for the user of the failures, as well as, how to identify whether the Servo-i unit has shown any failure indications.
Quantity in commerce: 1, 970 units
Distribution: Worldwide
Product codes and lots: Article # 64-87-800 Serial numbers 02400 - 03300

Product code CBK

K010925Class IIServoi Ventilator System, Model 64 87 800 E407eSiemens Elema AB / cleared 2001-12-18

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)