Enforcement Report - Week of September 26, 2012
-
Back to Previous Page
Product Detail
| 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). |
|---|---|
| Recall Number | Z-2401-2012 |
| Classification | Class II |
| Code Info | Serial Numbers: AR11J000164, AR12E000853, AR12E000856, AR12E000868, AR12E000920, AR12E000922, AR12E000923, AR12E000931, AR12E000944 AR12F001100, AR12F001298, |
| Product Distributed Qty | 11 units |
| Reason For Recall | Shipped with incorrect software |
Event Detail
| Event Id | 63004 |
|---|---|
| Product Type | Devices |
| Status | Terminated |
| Recalling Firm | ZOLL Medical Corporation |
| City | Chelmsford |
| State | MA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-08-16 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Distribution Pattern | Worldwide Distribution - US Nationwide including the states of: LA, MA, ME, NC, ND, NE, OH and the country of Germany. |
-
