Maquet Cardiovascular Us Sales, Llc recalls Servo-I ventilator system CO2 analyzer. Part number 65 23 588.

Recall date

January 12, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1224-2015

FDA classification

Class II

Brand / firm

Maquet Cardiovascular Us Sales, Llc

Sold / distributed

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, Sw…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Servo-I ventilator system CO2 analyzer. Part number 65 23 588.