Recall Z-2401-2012— ZOLL Medical Corporation

Name: FDA recall Z-2401-2012
Creator: U.S. Food and Drug Administration
Published: 2012-08-16

Class II · Terminated

Class II FDA medical device recall by ZOLL Medical Corporation, initiated 2012-08-16, terminated 2012-09-19. It names one FDA 510(k) clearance: K112432. 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).. Reason: Shipped with incorrect software.

Recalling firm: ZOLL Medical Corporation
Classification: Class II
Status: Terminated
Initiated: 2012-08-16
Terminated: 2012-09-19
Firm location: Chelmsford, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K112432 — ZOLL X SERIESZoll Medical Corporation, World Wide Headquarters·cleared 2012-03-21

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

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).

Reason for recall

Shipped with incorrect software

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