Reported Sep 26, 2012 · Terminated

Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the…

ZOLL Medical Corporation

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: ZOLL Medical Corporation · 269 Mill Road · Chelmsford, MA · 01824

Is this the product you have?

  • Zoll X Series Defibrillator/Pacemaker/Monitor
  • Product UsageThe product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In addition, the product may be used in synchronized mode to terminate certain atrial and ventricular tachycardias and other arrhythmias resistant to drug therapy. The X Series may be used for cardiac pacing in conscious or unconscious patients for up to a few hours duration as an alternative to endocardial stimulation. The X Series may be used for the monitoring a patients electrocardiogram (ECG)
Lot codes and dates
  • Serial Numbers
    • AR11J000164
    • AR12E000853
    • AR12E000856
    • AR12E000868
    • AR12E000920
    • AR12E000922
    • AR12E000923
    • AR12E000931
    • AR12E000944 AR12F001100
    • AR12F001298
Amount recalled
11 units

Where it was sold

Why it was recalled

Shipped with incorrect software

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 Sep 19, 2012 · Data as of Sep 19, 5:24 PM UTC

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