Z-0353-2012

Maquet Servo-S ventilator system Device Part number 66 40 440 Intended for treatment of and monitoring of...

Name: Z-0353-2012 Maquet Servo-S ventilator system Device Part number 66 40 440 Intended for treatment of and monitoring of...
Creator: Maquet Inc.
Published: 2011-09-19
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2011-09-19 / Terminated / root cause: supplier

FDA source

Maquet Inc. began a recall of Maquet Servo-S ventilator system Device Part number 66 40 440 Intended for treatment of and monitoring of patients in range of neonates, infants and adults... on 2011-09-19. The reason FDA records is "Servo-I and Servo--S ventilator systems are equipped with a specific revision of a printed circuit board (PC1772 revision 22) that includes a component that has generated a number of nuisance alarms due to technical...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-0353-2012
Status: Terminated
Initiated: 2011-09-19
Posted: 2011-12-02
Terminated: 2015-07-22
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Maquet Servo-S ventilator system Device Part number 66 40 440 Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory insufficiency; used only by healthcare providers in hospitals or healthcare facilities and for in hospital transport.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Servo-I and Servo--S ventilator systems are equipped with a specific revision of a printed circuit board (PC1772 revision 22) that includes a component that has generated a number of nuisance alarms due to technical error message 24 (TE 24).
Root cause tag: supplier
FDA root cause: Vendor change control
Action: The firm, Maquet Getinge Group, sent an " PRODUCT RECALL URGENT - MEDICAL DEVICE CORRECTIVE ACTION" letter dated September 19, 2011, to its customers. The letter describes the product, problem and actions to be taken. Maquet service team will contact the customers within two weeks of receiving this letter to schedule an on-site service of the affected equipment. If you have any questions, call technical support at our toll free number at 1-888-627-8383.
Quantity in commerce: 26 units
Distribution: Nationwide distribution.
Product codes and lots: Device Part number 66 40 440 Lot number S/N 16783-17318 510 k 041223 Device Listing No. B052264

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)