The Recall Desk
HighFDA (Devices)·Z-1177-2013·Announced 2013-05-08

Maquet SERVO-i Ventilator Battery Modules Recalled for Shorter Run Time

Maquet is recalling SERVO-i ventilator battery modules because some units have shorter battery run times than expected.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device (ventilator battery) where a defect (shorter run time) poses a risk of harm to patients if power fails, but the source text does not report any specific injuries, illnesses, or deaths, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Maquet Cardiovascular US Sales, LLC is recalling Maquet Getinge Group battery modules (Part #6487180) used with Maquet SERVO-i ventilator systems. The recall involves 90,000 battery modules manufactured between February 2010 and October 2012 with date codes between 1005 and 1243. These batteries are intended to provide backup power to ventilators used for treating and monitoring patients with respiratory failure or insufficiency.

The recall was initiated because, in a very small number of cases, some battery modules distributed after January 31, 2010 have a shorter battery run time than expected. This issue may affect the ability of the ventilator to maintain settings and stored data during an AC power failure or during intra-hospital transportation.

The affected battery modules were distributed worldwide, including nationwide in the United States and in numerous other countries. Users of Maquet SERVO-i ventilator systems should check their battery module part numbers and date codes to determine if they are affected. The source text does not specify specific consumer actions beyond the recall notice.

The recalled product

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 respirat
Affected units
90,000

Distribution

Distributed nationwide across the United States.