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Maquet Cardiovascular Us Sales, Llc recalls Servo-I ventilator system CO2 analyzer. Part number 65 23 588.
Recalled March 11, 2015 · FDA recall Z-1224-2015 · Maquet Cardiovascular Us Sales
Hazard
A calibration problem was detected in a specific number of the Servo-I ventilator system CO2 analyzer models that may have been caused by the module's internal circuit board function. · FDA Class II
Units
486 units
Sold at
Worldwide distribution - USA nationwide, Austria, Australia, Belgium, Chile, Canada, Colombia, Ecuador, Egypt, Finland, France, Germany, Hungary, Iceland, India, Indonesia, Iraq, Italy, Japan, Libya, Netherlands, Norway, Panama, Peru, Portugal, Romania, Russia, Saudi Arabia, South Africa, Spain, Sweden, Thailand, Tunisia, Turkey, Ukraine, and United Kingdom.
Description
A calibration problem was detected in a specific number of the Servo-I ventilator system CO2 analyzer models that may have been caused by the module's internal circuit board function.
Product
Servo-I ventilator system CO2 analyzer. Part number 65 23 588.
Manufacturer(s)
Maquet Cardiovascular Us Sales, Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →