Z-0872-2009

SERVO Ventilator 300A (SV300A); Maquet Critical Care Ab, Solna, Sweden. The device is intended for general...

Name: Z-0872-2009 SERVO Ventilator 300A (SV300A); Maquet Critical Care Ab, Solna, Sweden. The device is intended for general...
Creator: MAQUET Inc.
Published: 2008-12-19
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2008-12-19 / Terminated / root cause: design

FDA source

MAQUET Inc. began a recall of SERVO Ventilator 300A (SV300A); Maquet Critical Care Ab, Solna, Sweden. The device is intended for general and critical ventilatory care of adult, pediatric... on 2008-12-19. The reason FDA records is "SERVO Ventilator 300A could cause hypoventilation if the use of the PC or PRVC mode with the Automode function set to "On" in Neonatal and Pediatric patient ranges with small tidal volumes and short set inspiratory rise...". 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-0872-2009
Status: Terminated
Initiated: 2008-12-19
Posted: 2009-02-03
Terminated: 2009-07-08
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: SERVO Ventilator 300A (SV300A); Maquet Critical Care Ab, Solna, Sweden. The device is intended for general and critical ventilatory care of adult, pediatric, infant and neonatal patients. The unit is designed to be used at the bedside and for intra-hospital transport. It is not intended for transport use in ambulances or in helicopters in the US market.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: SERVO Ventilator 300A could cause hypoventilation if the use of the PC or PRVC mode with the Automode function set to "On" in Neonatal and Pediatric patient ranges with small tidal volumes and short set inspiratory rise time.
Root cause tag: design
FDA root cause: Device Design
Action: URGENT: Device Correction letters were sent out on December 22, 2008. Letters alert users to the potential problem and the situation in which it may occur. Letter indicate the set inspiratory rise time should be set in the range of 7-10% and that the humidifier chamber water level be maintained according to manufacturers instructions. The letter is enclosed as a supplement to the SV300A Operating Manual. Consignees were directed to complete a "Device Correction-Customer Fax Response" to indicate number of units of the affected product and that they followed the instructions for including the attached supplemental instructions to the operating manual. For questions about the recall, contact your local Maquet, Inc. representative.
Quantity in commerce: 3,688 units in US
Distribution: Nationwide
Product codes and lots: All units of SV300A.

Product code CBK

K970839Class IIServo Ventilator 300ASiemens Elema AB / cleared 1997-10-14

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)