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Terminated

Zoll E Series BLS Defibrillator/Pacemaker/Monitor Software versions 7.10 and 7.11 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 E 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 E Series may be used for the monitoring a patients electrocardiogram (ECG).

FDA Recall Z-2294-2011 · Posted 2011-05-25

Recalling FirmZOLL Medical Corporation
Recall StatusTerminated
Product CodeMKJ
Date Initiated2011-04-21
Date Terminated2014-01-23
Product Quantity874 units

Reason for Recall

Zoll E Series BLS Defibrillator may fail to auto charge and deliver energy

Firm Action

The firm, Zoll, sent an "Urgent Medical Device Correction" letter dated April 22, 2011 via UPS to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately alert all E Series BLS users to this problem; instruct users to not touch patient and keep the patient still during ECG analysis, Instruct users that if they experience this problem, to press the Analyze button again, and contact ZOLL Technical Service for the software upgrade kit. The letter also states that affected units can remain in service until the software has been updated. If you have any questions, please contact 24/7 technical support at 1 (800) 348-9011 or +1 (978) 421-9460.

Root Cause

Software design

Distribution Pattern

Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, Finland, Germany, Malaysia and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042007ZOLL E SERIES DEFIBRILLATORZoll Medical Corp · 2005-04-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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