Z-0588-2010

Maquet Servo Ventilator 300/300A (SV300) Siemens - Elema AB

Name: Z-0588-2010 Maquet Servo Ventilator 300/300A (SV300) Siemens - Elema AB
Creator: MAQUET Inc.
Published: 2009-11-17
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2009-11-17 / Terminated / root cause: design

FDA source

MAQUET Inc. began a recall of Maquet Servo Ventilator 300/300A (SV300) Siemens - Elema AB on 2009-11-17. The reason FDA records is "Some Servo Ventilators 300/300A and Servo Ventilator 900C/D/E should not be used with a system that may generate negative pressure below -100 cm H2O (Closed system suctioning) due to the risk of damaging the...". 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-0588-2010
Status: Terminated
Initiated: 2009-11-17
Posted: 2010-01-05
Terminated: 2012-06-04
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Maquet Servo Ventilator 300/300A (SV300) Siemens - Elema AB,
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Some Servo Ventilators 300/300A and Servo Ventilator 900C/D/E should not be used with a system that may generate negative pressure below -100 cm H2O (Closed system suctioning) due to the risk of damaging the ventilator's pressure transducers.
Root cause tag: design
FDA root cause: Device Design
Action: Maquet sent Device Correction letters commencing 11/17/09 and ending 11/23/09 by Federal Express.
Quantity in commerce: 20837 (7847 of those in US)
Distribution: Worldwide distribution
Product codes and lots: Serial numbers 00410-24999. Ventilators in the specific range that are marked with one of the following labels are already equipped with the new type ot pressure transducer. 1. Upgrade EM008/02/1; 2. Upgrade SV300 66 82 745 SV900 66 82 747

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)