Recall Z-1224-2015— Maquet Cardiovascular Us Sales, Llc

Name: FDA recall Z-1224-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-12

Class II · Terminated

Class II FDA medical device recall by Maquet Cardiovascular Us Sales, Llc, initiated 2015-01-12, terminated 2017-05-15. It names one FDA 510(k) clearance: K123149. Product: Servo-I ventilator system CO2 analyzer. Part number 65 23 588.. Reason: 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..

Recalling firm: Maquet Cardiovascular Us Sales, Llc
Classification: Class II
Status: Terminated
Initiated: 2015-01-12
Terminated: 2017-05-15
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K123149 — SERVO-I VENTILATOR SYSTEMMaquet Critical Care AB·cleared 2014-06-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.