Z-2628-2011

Servo-i Ventilator Systems; Article number 64 87 800 Intended for treatment and monitoring of patients in the...

Name: Z-2628-2011 Servo-i Ventilator Systems; Article number 64 87 800 Intended for treatment and monitoring of patients in the...
Creator: Maquet Inc.
Published: 2011-04-20
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2011-04-20 / Terminated

FDA source

Maquet Inc. began a recall of Servo-i Ventilator Systems; Article number 64 87 800 Intended for treatment and monitoring of patients in the range of neonates, infants and adults with... on 2011-04-20. The reason FDA records is "Through customer complaints, Maquet has been informed that SERVO-i ventilators have stopped to ventilate and have generated three different technical error codes". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2628-2011
Status: Terminated
Initiated: 2011-04-20
Posted: 2011-06-23
Terminated: 2013-09-17
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Servo-i Ventilator Systems; Article number 64 87 800 Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory insufficiency; these are only to be used by healthcare providers in hospitals or healthcare facilities and for in-hospital transport. These are not to be used with any anesthetic agents.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Through customer complaints, Maquet has been informed that SERVO-i ventilators have stopped to ventilate and have generated three different technical error codes.
FDA root cause: Other
Action: Maquet Inc. sent an URGENT DEVICE SAFETY ALERT letter dated April 20, 2011, to all affected customers via Federal Express. The letter identified the product, the problem and the action needed to be taken by the customer. The letter informs the user of the issue and provides additional instruction and how the existing manual should be updated. Customers are asked to fill out the attached response form and fax it to 1-973-807-9210. The following warning will be included in all user's manuals delivered with new ventilators: 'Warning ! The Servo-i Ventilator System is not intended to be used during radiotherapy, since this may cause system malfunction. Warning! The Servo-s Ventilator System is not intended to be used during radiotherapy, since this may cause system malfunction.' Additionally the warning stated above will be included in the format of a sticker with the yearly preventive maintenance kit for Servo-i and SErvo-s to update exiting User's manuals for the installed base of Servo-i and SErvo-s ventilators. A maintenance report form will also be included in the kit which serves as an acknowledgement from the user that the sticker has been added to an affected ventilator unit's operating manual. For further questions, please call (973) 709-7660.
Quantity in commerce: 43210 units worlwide, 14412 units in the US
Distribution: Worldwide Distribution - USA (nationwide)
Product codes and lots: Article number 64 87 800; all units

Product code CBK

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)