Reported Mar 11, 2015 · Terminated

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

Maquet Cardiovascular US Sales, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Maquet Cardiovascular Us Sales, Llc · 45 Barbour Pond Drive · Wayne, NJ · 07470

Is this the product you have?

  • Servo-I ventilator system CO2 analyzer. Part number 65 23 588.
Lot codes and dates
  • Serial Numbers

    202 of 202 codes

    • 9592
    • 9604
    • 9606
    • 9608
    • 9609
    • 9610
    • 9611
    • 9612
    • 9616
    • 9617
    • 9618
    • 9619
    • 9620
    • 9621
    • 9625
    • 9626
    • 9627
    • 9636
    • 9643
    • 9645
    • 9646
    • 9647
    • 9648
    • 9649
    • 9650
    • 9651
    • 9652
    • 9653
    • 9654
    • 9655
    • 9656
    • 9657
    • 9658
    • 9659
    • 9660
    • 9661
    • 9662
    • 9664
    • 9666
    • 9667
    • 9668
    • 9669
    • 9670
    • 9671
    • 9674
    • 9676
    • 9677
    • 9678
    • 9679
    • 9680
    • 9681
    • 9682
    • 9683
    • 9684
    • 9686
    • 9687
    • 9689
    • 9690
    • 9692
    • 9697
Amount recalled
486 units

Where it was sold

  • Nationwide

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 15, 2017 · Data as of Sep 19, 5:32 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.