Z-1177-2013Class I

Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180). Battery...

Name: Z-1177-2013 Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180). Battery...
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2013-03-07
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2013-03-07 / Terminated / root cause: design

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180). Battery for use with the SERVO-i Ventilator System. The... on 2013-03-07. FDA classified it as Class I and gives the reason as "When using the SERVO-i on battery power, in a very small number of cases, some battery modules distributed after January 31, 2010 have a shorter battery run time than expected". 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-1177-2013
Classification: Class I
Status: Terminated
Initiated: 2013-03-07
Posted: 2013-04-26
Terminated: 2016-08-11
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180). Battery for use with the SERVO-i Ventilator System. The SERVO-i Ventilator System is intended for treating and monitoring patients ranging from neonates to adults with respiratory failure or insufficiency. The ventilator is equipped with at least 2, NiMH battery modules (Part No. 6487180) which automatically supply 12V DC Power in case of an AC power failure, ensuring that ventilator settings and stored data remain intact in the event of an AC power failure. The battery modules give the user a possibility to use the SERVO-i during intra-hospital transportation.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: When using the SERVO-i on battery power, in a very small number of cases, some battery modules distributed after January 31, 2010 have a shorter battery run time than expected.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Maquet Getinge Group" sent "Field Safety Notices"/"Field Safety Notice Confirmation Forms" dated March 7 & 11 2013 via Federal Express and an updated Field Safety Notices dated April 15, 2013 to its customers. The Field Safety Notices identifies the problem, product, risk factors and actions to be taken by the customer. The customers were instructed to reconnect the ventilator to mains power immediately or add additional battery modules in case of 'low battery voltage' alarm; ensure that at least two fully charged batteries are installed at all times, and that sufficient resuscitation equipment is accessible to the ventilator; identify and immediately replace battery modules with date codes 1005-1243, that have generated either: a "low battery voltage" alarm or a "replace battery" message, prior to the expiry date; and complete and return the enclosed Field Safety Notice Confirmation Form by e-mailing a scanned copy to [email protected] or via fax at (973) 807-1832. If you have any questions or require replacement batteries, please contact your local MAQUET representative, or MAQUET Customer Service at 888-627-8383 (press option 2, followed by option 3) Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST.
Quantity in commerce: 90,000 units (batteries)
Distribution: Worldwide distribution: USA (nationwide) and countries of: ALGERIA, ANDORRA, ANTILLES (Netherlands), ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBADJAN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOTSWANA, BRAZIL, BRUNEI, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CONGO, COSTA RICA, CROATIA, CUBA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, YUGOSLAVIA (Former), FIJI, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, KENYA, KUWAIT, KYRGYZSTAN, LATVIA, LIBYA, LITHUANIA, LUXEMBURG, MACAU, MACEDONIA, MALAYSIA, MALDIVES, MARTINIQUE (French), MEXICO, MOLDAVIA, MOROCCO, NEPAL, NETHERLANDS, NEW CALEDONIA (French), NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PANAMA, PAPUA NEW GUINEA, PARAGUAY, PERU, PHILIPPINES, POLAND, POLYNESIA (French), PORTUGAL, QATAR, REUNION (French), ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SEYCHELLES, SINGAPORE, SLOVAK REPUBLIC, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SUDAN, SURINAM, SWEDEN, SWITZERLAND, SYRIA, TADJIKISTAN, TAIWAN, TANZANIA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VATICAN city state, VENEZUELA, VIETNAM and YEMEN.
Product codes and lots: SERVO-i Battery Module part number is 6487180. Notice pertains to Battery Modules manufactured between February 2010 and October 2012 with date codes between 1005 and 1243.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1177-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1177-2013	Class I	Terminated	Voluntary: Firm initiated	2013-05-08	2013-04-26

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)