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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency 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."
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…
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Affected units
- 90,000
Distribution
Distributed nationwide across the United States.
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