Z-1252-2009

Servo Ventilator 300 (Model SV300) and Servo Ventilator 300 (Model SV300A). The SV300 is intended for general...

Name: Z-1252-2009 Servo Ventilator 300 (Model SV300) and Servo Ventilator 300 (Model SV300A). The SV300 is intended for general...
Creator: MAQUET Inc.
Published: 2009-03-23
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2009-03-23 / Terminated / root cause: design

FDA source

MAQUET Inc. began a recall of Servo Ventilator 300 (Model SV300) and Servo Ventilator 300 (Model SV300A). The SV300 is intended for general and critical ventilatory care for use on adults... on 2009-03-23. The reason FDA records is "The expiratory valve in the SV 300 ventilator may stay in the open position if the printed circuit board fails". 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-1252-2009
Status: Terminated
Initiated: 2009-03-23
Posted: 2009-05-12
Terminated: 2009-11-16
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Servo Ventilator 300 (Model SV300) and Servo Ventilator 300 (Model SV300A). The SV300 is intended for general and critical ventilatory care for use on adults, pediatric, infant and neonatal patients. The unit is designed to be used at the bedside for intra-hospital transport.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: The expiratory valve in the SV 300 ventilator may stay in the open position if the printed circuit board fails.
Root cause tag: design
FDA root cause: Device Design
Action: An "Urgent: Device Correction" letter dated March 23, 2009 was sent by Federal Express to customers. The letter described the affected product, problem, indications, potential hazard and actions for users. Customers were instructed to complete the "Device Correction -- Customer Fax Response" form and return via fax (732-667-1903) to Maquet Inc. RA/QA. Direct questions to your local Maquet Inc. representative.
Quantity in commerce: 7,847 units
Distribution: Nationwide Distribution.
Product codes and lots: All units manufactured prior to June 2002.

Product code CBK

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)