Z-1362-2012

Servo-i ventilator system

Name: Z-1362-2012 Servo-i ventilator system
Creator: Maquet Inc.
Published: 2011-12-22
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2011-12-22 / Terminated / root cause: design

FDA source

Maquet Inc. began a recall of Servo-i ventilator system Product Usage: Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory... on 2011-12-22. The reason FDA records is "The Servo-i and Servo-s ventilator systems equipped with specific revision os of the AC/DC convertor can result in electric shock during servicing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1362-2012
Status: Terminated
Initiated: 2011-12-22
Posted: 2012-04-03
Terminated: 2013-10-22
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Servo-i ventilator system Product Usage: Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: The Servo-i and Servo-s ventilator systems equipped with specific revision os of the AC/DC convertor can result in electric shock during servicing.
Root cause tag: design
FDA root cause: Device Design
Action: Maquet sent a Product Recall Urgent-Medical Device Corrective Action letter dated December 22, 2011 to all affected customers. The letter identified the affected products, patient risk, product issue and actions to be taken. Customers were instructed to complete and return the attached Customer Fax Response form as soon as possible. Maquet Field Service Technicians will update all affected products at all the concerned customer sites. Customers are advised untill Maquet has updated all the affected products (all of which are still under warranty), inform all the concerned biomedical staff about the content of this Device Correction Letter. For technical support call 1-888-627-8383.
Quantity in commerce: 647 US; 2462 Foreign; 27 Spare Parts Foreign
Distribution: USA Nationwide Distribution
Product codes and lots: 510k k041223 B052264 Article 64 87 800 Serial numbers 56001-58411

Product code CBK

K041223Class IIModification to Servo-I Ventilator System, Model 64 87 800 E407eMaquet Critical Care AB / cleared 2004-07-29

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)