Z-0571-05

Servo-Ventilator, SV300/300A, Part numbers 6070391 and 6424704. The Safety Alert action targets customers...

Name: Z-0571-05 Servo-Ventilator, SV300/300A, Part numbers 6070391 and 6424704. The Safety Alert action targets customers...
Creator: Maquet Inc
Published: 2005-01-03
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2005-01-03 / Terminated

FDA source

Maquet Inc began a recall of Servo-Ventilator, SV300/300A, Part numbers 6070391 and 6424704. The Safety Alert action targets customers with Unit Serial numbers 24578 and lower. Manuf... on 2005-01-03. The reason FDA records is "Failures of the air and oxygen gas modules occurred because of misuse/non-compliance of directions". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0571-05
Status: Terminated
Initiated: 2005-01-03
Posted: 2005-03-08
Terminated: 2005-09-08
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Servo-Ventilator, SV300/300A, Part numbers 6070391 and 6424704. The Safety Alert action targets customers with Unit Serial numbers 24578 and lower. Manuf. Maquet Critial Care AB, SE-171 95 Solna, Sweden.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Failures of the air and oxygen gas modules occurred because of misuse/non-compliance of directions.
FDA root cause: Other
Action: Customer letter mailed on January 3, 2005 via certified postage, with return self-addressed postcards that customers must complete to acknowledge receipt of the instructions to refer to their Service and Operating Manuals.
Quantity in commerce: 7920 units
Distribution: The ventilators were distributed to hospitals nationwide. There are 33 VA Medical Center and DOD hospitals nationwide.
Product codes and lots: All units with the Serial Numbers 24578 and lower. Total of 7920 units.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)