Recall Z-1177-2013— Maquet Cardiovascular Us Sales, Llc

Name: FDA recall Z-1177-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-07

Class I · Terminated

Class I FDA medical device recall by Maquet Cardiovascular Us Sales, Llc, initiated 2013-03-07, terminated 2016-08-11. It names one FDA 510(k) clearance: K041223. 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.. Reason: 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..

Recalling firm: Maquet Cardiovascular Us Sales, Llc
Classification: Class I
Status: Terminated
Initiated: 2013-03-07
Terminated: 2016-08-11
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K041223 — MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407EMaquet Critical Care AB·cleared 2004-07-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.