Z-2442-2008

SERVO-i Ventilator System Maquet Critical Care, Solna, Sweden. The product is intended for treatment and...

Name: Z-2442-2008 SERVO-i Ventilator System Maquet Critical Care, Solna, Sweden. The product is intended for treatment and...
Creator: MAQUET Inc.
Published: 2008-07-08
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2008-07-08 / Terminated / root cause: manufacturing process

FDA source

MAQUET Inc. began a recall of SERVO-i Ventilator System Maquet Critical Care, Solna, Sweden. The product is intended for treatment and monitoring of patients in the range of neonates... on 2008-07-08. The reason FDA records is "Maquet became aware of potentially defective crimpings at the point connector attached to the cable in SERVO-i and SERVO-s ventilators". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2442-2008
Status: Terminated
Initiated: 2008-07-08
Posted: 2008-09-23
Terminated: 2008-12-23
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: SERVO-i Ventilator System Maquet Critical Care, Solna, Sweden. The product is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Maquet became aware of potentially defective crimpings at the point connector attached to the cable in SERVO-i and SERVO-s ventilators.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Urgent - Device Correction notices were sent out to all customers on July 7, 2008. The letter informed the customers of the affected product, and associated hazards. The letter instructed customers to take an inventory of the product and it provided actions to be taken until affected products are replaced. Contact Maquet at 1-888-627-8383#1, for assistance.
Quantity in commerce: 122 units (SERVO-i and SERVO-s) units in United States
Distribution: Worldwide.
Product codes and lots: Article number 64 87 800 Serial numbers: 34034, 34035, 34050, 34052, 34053, 34054, 34058, 34060 through 34083, 34085, 34086, 34087, 34088, 34090, 34096, 34099 through 34287, 34293, 34294, 34295, 34296, 34298, 34299, 34302, 34303, 34305, 34309, 34313, 34315, 34319, 34230, 34323, 34324, 34326, 34329, 34330, 34343, 34345, 34348, 34350, 34357, 34360, 34376, 34384, 34390, 34427, 34490, and 34530.

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)