FDA-Device2015-03-11Class II
Servo-I ventilator system CO2 analyzer. Part number 65 23 588.
Maquet Cardiovascular Us Sales, Llc
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.
Sold states
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.
Affected count
486 units
Manufactured in
45 Barbour Pond Drive, N/A, Wayne, NJ, United States
Products
Servo-I ventilator system CO2 analyzer. Part number 65 23 588.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1224-2015Don't want to check this manually?
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