Z-0878-05

Servo-i Ventilator

Name: Z-0878-05 Servo-i Ventilator
Creator: Maquet Inc
Published: 2005-03-24
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2005-03-24 / Terminated

FDA source

Maquet Inc began a recall of Servo-i Ventilator on 2005-03-24. The reason FDA records is "Complaints about batteries indicating a satisfying remaining time but after a short time suddenly shut off without giving alarms to indicate short remaining battery back-up time. (Power off alarm will be given)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0878-05
Status: Terminated
Initiated: 2005-03-24
Posted: 2005-06-08
Terminated: 2005-09-08
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Servo-i Ventilator
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Complaints about batteries indicating a satisfying remaining time but after a short time suddenly shut off without giving alarms to indicate short remaining battery back-up time. (Power off alarm will be given).
FDA root cause: Other
Action: Maquet sent out a Safety alert Letter on 3/31/2005 to all users of the Servo-i.
Quantity in commerce: 4379 units
Distribution: The ventilators were distributed nationwide to hosptials and clinics.
Product codes and lots: All Servo-i units with serial numbers below 17617.

Product code CBK

K040221Class IIServo-I Ventilator System, Model 64 87 800 E407eMaquet Critical Care AB / cleared 2004-02-20

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)