Z-2401-2012Class II

Zoll X Series Defibrillator/Pacemaker/Monitor

Name: Z-2401-2012 Zoll X Series Defibrillator/Pacemaker/Monitor
Creator: ZOLL Medical Corporation
Published: 2012-08-16
License: https://open.fda.gov/license/

ZOLL Medical Corporation / initiated 2012-08-16 / Terminated / root cause: manufacturing process

FDA source

ZOLL Medical Corporation began a recall of Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the purpose of converting ventricular... on 2012-08-16. FDA classified it as Class II and gives the reason as "Shipped with incorrect software". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2401-2012
Classification: Class II
Status: Terminated
Initiated: 2012-08-16
Posted: 2012-09-17
Terminated: 2012-09-19
Recalling firm: ZOLL Medical Corporation
Product: Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The 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).
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Shipped with incorrect software
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Zoll Medical telephoned affected customers on August 16, 2012. Customers were informed of the affected product, problem and actions to be taken. Customers were instructed to remove and return the affected product for replacement. For question contact ZOLL's Technical Support.
Quantity in commerce: 11 units
Distribution: Worldwide Distribution - US Nationwide including the states of: LA, MA, ME, NC, ND, NE, OH and the country of Germany.
Product codes and lots: Serial Numbers: AR11J000164, AR12E000853, AR12E000856, AR12E000868, AR12E000920, AR12E000922, AR12E000923, AR12E000931, AR12E000944 AR12F001100, AR12F001298.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2401-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2401-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-17

Product code MKJ

K112432Class IIIZoll X SeriesZoll Medical Corporation, World Wide Headquarters / cleared 2012-03-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)